BIOTHERM SUNFITNESS PROTECTIVE SELF-TANNER TINTED CREAM, SPF 15 (2007 formulation) || Skin Deep: Cosmetic Safety Reviews

BIOTHERM SUNFITNESS PROTECTIVE SELF-TANNER TINTED CREAM, SPF 15 (2007 FORMULATION)

last updated: 12/01/07 brand: Biotherm by L'Oréal

SCORE

high hazard (out of 10)

79%

data gap

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99% of sunless tannings have lower concerns

COMPANY POLICIES

Compact for Safe Cosmetics
Non-signer: This company has not signed the Compact.

Animal Testing Policy
This company conducts animal tests.

Given the incomplete information made available by companies and the government, EWG provides additional information on personal care product ingredients from the published scientific literature. The chart below indicates that research studies have found that exposure to one or more ingredients in this product -- not the product itself -- caused the indicated health effect(s) in the studies reviewed by Skin Deep researchers. Actual health risks, if any, will vary based on the level of exposure to the ingredient and individual susceptibility -- information not available in Skin Deep.

Ingredients in this product are linked to:
	Cancer
	Developmental/reproductive toxicity
	Violations, restrictions & warnings
	Allergies/immunotoxicity
	Other concerns for ingredients used in this product: Neurotoxicity, Endocrine disruption, Persistence and bioaccumulation, Organ system toxicity (non-reproductive), Miscellaneous, Multiple, additive exposure sources, Irritation (skin, eyes, or lungs), Enhanced skin absorption, Contamination concerns, Occupational hazards, Biochemical or cellular level changes

Note: This product formulation was obtained from the FDA VCRD.

Ingredients from packaging: WATER, OCTOCRYLENE, TRI-C14-15 ALKYL CITRATE, ARACHIDYL ALCOHOL, CARAMEL, PEG-100 STEARATE, GLYCERYL STEARATE, DIMETHICONE, SODIUM POLYACRYLOYLDIMETHYL TAURATE, BEHENYL ALCOHOL, FRAGRANCE, ETHYLHEXYL METHOXYCINNAMATE, ARACHIDYL GLUCOSIDE, PHENOXYETHANOL, MICA, METHYLPARABEN, TITANIUM DIOXIDE, POLYSORBATE 80, CALCIUM GLUCONATE, MAGNESIUM GLUCONATE, DISODIUM EDTA, GLYCINE SOJA (SOYBEAN) OIL, BENZOPHENONE-3, TOCOPHEROL, PROPYLPARABEN, SORBITAN OLEATE, VITREOSCILLA FERMENT, CITRUS MEDICA LIMONUM (LEMON) FRUIT EXTRACT, ETHYLPARABEN, ISOBUTYLPARABEN, IODOPROPYNYL BUTYLCARBAMATE, BUTYLPARABEN, DC RED #21, DIHYDROXYACETONE, ETHYLHEXYL SALICYLATE, PROPYLENE GLYCOL, ISOHEXADECANE, C12-15 ALKYL BENZOATE, GLYCERIN

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ingredients

	score	data gap	concerns
METHYLPARABEN	10	63%	Violations, restrictions & warnings, Endocrine disruption, Allergies/immunotoxicity, Organ system toxicity (non-reproductive), Irritation (skin, eyes, or lungs), Biochemical or cellular level changes
OXYBENZONE (BENZOPHENONE-3) (Active Ingredient)	9	55%	Developmental/reproductive toxicity, Violations, restrictions & warnings, Endocrine disruption, Allergies/immunotoxicity, Persistence and bioaccumulation, Enhanced skin absorption, Biochemical or cellular level changes
FRAGRANCE	8	100%	Neurotoxicity, Allergies/immunotoxicity, Miscellaneous
OCTINOXATE (OCTYL METHOXYCINNAMATE) ETHYLHEXYL METHOXYCINNAMATE (Active Ingredient)	8	65%	Violations, restrictions & warnings, Endocrine disruption, Allergies/immunotoxicity, Persistence and bioaccumulation, Enhanced skin absorption, Biochemical or cellular level changes
PEG-100 STEARATE	4	69%	Organ system toxicity (non-reproductive), Irritation (skin, eyes, or lungs), Contamination concerns (ETHYLENE OXIDE, 1,4-DIOXANE, ETHYLENE OXIDE, 1,4-DIOXANE)
BUTYLPARABEN	6	79%	Developmental/reproductive toxicity, Endocrine disruption, Allergies/immunotoxicity, Organ system toxicity (non-reproductive), Biochemical or cellular level changes
IODOPROPYNYL BUTYLCARBAMATE	4	65%	Violations, restrictions & warnings, Allergies/immunotoxicity, Organ system toxicity (non-reproductive)
ETHYLPARABEN	5	80%	Endocrine disruption, Allergies/immunotoxicity, Organ system toxicity (non-reproductive)
DIHYDROXYACETONE	5	73%	Violations, restrictions & warnings, Multiple, additive exposure sources
PROPYLPARABEN	5	71%	Developmental/reproductive toxicity, Endocrine disruption, Allergies/immunotoxicity, Organ system toxicity (non-reproductive)
TITANIUM DIOXIDE (NON-NANO)	1	81%	Allergies/immunotoxicity, Organ system toxicity (non-reproductive), Occupational hazards, Biochemical or cellular level changes
SOLVENT RED 43 DC RED #21	4	73%	Violations, restrictions & warnings
OCTISALATE ETHYLHEXYL SALICYLATE (Active Ingredient)	3	68%	Violations, restrictions & warnings, Allergies/immunotoxicity, Irritation (skin, eyes, or lungs), Enhanced skin absorption
PHENOXYETHANOL	4	67%	Violations, restrictions & warnings, Allergies/immunotoxicity, Organ system toxicity (non-reproductive), Irritation (skin, eyes, or lungs), Occupational hazards
PROPYLENE GLYCOL	4	60%	Allergies/immunotoxicity, Organ system toxicity (non-reproductive), Irritation (skin, eyes, or lungs), Enhanced skin absorption
ISOBUTYLPARABEN	3	83%	Allergies/immunotoxicity, Organ system toxicity (non-reproductive)
DISODIUM EDTA	3	78%	Neurotoxicity, Organ system toxicity (non-reproductive), Enhanced skin absorption
MICA	3	75%	Persistence and bioaccumulation, Organ system toxicity (non-reproductive), Occupational hazards
DIMETHICONE	2	74%	Violations, restrictions & warnings
OCTOCRYLENE (Active Ingredient)	3	71%	Violations, restrictions & warnings, Biochemical or cellular level changes
TOCOPHEROL	2	87%	Contamination concerns (HYDROQUINONE)
POLYSORBATE-80	2	80%	Developmental/reproductive toxicity
GLYCERIN	2	74%	Organ system toxicity (non-reproductive), Occupational hazards
ARACHIDYL ALCOHOL	0	94%	none identified
C12-15 ALKYL BENZOATE	0	94%	none identified
ISOHEXADECANE	0	94%	none identified
CARAMEL	1	92%	none identified
MAGNESIUM GLUCONATE	1	89%	none identified
GLYCERYL MONOSTEARATE GLYCERYL STEARATE	1	88%	none identified
GLYCINE SOJA (SOYBEAN) OIL	1	88%	none identified
CALCIUM GLUCONATE	1	86%	none identified
SORBITAN OLEATE	1	86%	none identified
ARACHIDYL GLUCOSIDE	0	100%	none identified
CITRUS MEDICA LIMONUM (LEMON) EXTRACT CITRUS MEDICA LIMONUM (LEMON) FRUIT EXTRACT	0	100%	none identified
SODIUM POLYACRYLOYLDIMETHYL TAURATE	0	100%	none identified
TRI-C14-15 ALKYL CITRATE	0	100%	none identified
VITREOSCILLA FERMENT	0	100%	none identified
BEHENYL ALCOHOL	0	93%	none identified
WATER	0	0%	innocuous

Cancer*

*This table includes all possible cancer concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
One or more in vitro tests on mammalian cells show positive mutation results		TITANIUM DIOXIDE (NON-NANO), TOCOPHEROL
One or more in vitro tests non-mammalian cells show positive mutation results		PHENOXYETHANOL, OXYBENZONE (BENZOPHENONE-3), GLYCINE SOJA (SOYBEAN) OIL
One or more animal studies show tumor formation at moderate doses		PEG-100 STEARATE
One or more in vitro tests on mammalian cells show positive mutation results		SORBITAN OLEATE, PROPYLPARABEN, PROPYLENE GLYCOL, POLYSORBATE-80, METHYLPARABEN, GLYCERIN, ETHYLPARABEN, DISODIUM EDTA, DIHYDROXYACETONE, CARAMEL, BUTYLPARABEN
Cancer - not classifiable/not likely to be human carcinogen		SOLVENT RED 43

Developmental/reproductive toxicity*

*This table includes all possible developmental/reproductive toxicity concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
One or more animal studies show reproductive effects at high doses		PEG-100 STEARATE, ETHYLPARABEN, DISODIUM EDTA
One or more animal studies show reproductive effects at moderate doses		OCTINOXATE (OCTYL METHOXYCINNAMATE)
One or more animal studies show reproductive effects at moderate doses		PROPYLENE GLYCOL, GLYCERIN
Limited evidence of developmental toxicity		OXYBENZONE (BENZOPHENONE-3)
One or more animal studies show any effects at low doses		PROPYLPARABEN
One or more animal studies show reproductive effects at very low doses		POLYSORBATE-80,
One or more animal studies show any effects at very low doses		BUTYLPARABEN

Violations, restrictions & warnings*

*This table includes all possible violations, restrictions & warnings concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
Determined safe for use in cosmetics, subject to concentration or use limitations - Safe for use in cosmetics with some qualifications		PROPYLENE GLYCOL, PEG-100 STEARATE, IODOPROPYNYL BUTYLCARBAMATE
Recommended restricted in cosmetics - use, concentration, or manufacturing restrictions - Product type restrictions or differences noted in safety assessment by industry panel		DIMETHICONE
Restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions - Japan - restricted for use in some types of cosmetics (concentration limit)	products for use around the eyes; products for use on the lips	OCTINOXATE (OCTYL METHOXYCINNAMATE)
Restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions - Japan - restricted for use in some types of cosmetics (concentration limit)		OXYBENZONE (BENZOPHENONE-3), OCTISALATE, IODOPROPYNYL BUTYLCARBAMATE, PHENOXYETHANOL, IODOPROPYNYL BUTYLCARBAMATE, OCTOCRYLENE
Violation of government restrictions - Banned or found unsafe for use in cosmetics		SOLVENT RED 43, METHYLPARABEN
Violation of government restrictions - Restricted in cosmetics; use, concentration, or manufacturing restrictions - Color additive not approved by FDA for cosmetics used around eyes	products for use around the eyes	DIHYDROXYACETONE

Neurotoxicity*

*This table includes all possible neurotoxicity concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
One or more animal studies show brain and nervous system effects at high doses		PROPYLENE GLYCOL, POLYSORBATE-80, OXYBENZONE (BENZOPHENONE-3), GLYCERIN, CALCIUM GLUCONATE
One or more animal studies show brain and nervous system effects at low doses		DISODIUM EDTA
One or more animal studies show brain and nervous system effects at moderate doses		PHENOXYETHANOL, METHYLPARABEN
Moderate evidence of human neurotoxicity		FRAGRANCE

Endocrine disruption*

*This table includes all possible endocrine disruption concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
One or more animal studies show endocrine system disruption at high doses		GLYCERIN, DISODIUM EDTA
One or more animal studies show endocrine disruption at moderate doses		ISOBUTYLPARABEN
Human any disruptor - moderate evidence		OXYBENZONE (BENZOPHENONE-3)
Human any disruptor - strong evidence		OCTINOXATE (OCTYL METHOXYCINNAMATE), PROPYLPARABEN, METHYLPARABEN, ETHYLPARABEN, BUTYLPARABEN

Allergies/immunotoxicity*

*This table includes all possible allergies/immunotoxicity concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
Limited evidence of skin and immune system toxicity		PHENOXYETHANOL
One or more animal studies show gastrointestinal effects at moderate doses		MICA
One or more human case studies show possible photoallergic effects		OCTINOXATE (OCTYL METHOXYCINNAMATE)
One or more animal studies show immune effects at low doses		TITANIUM DIOXIDE (NON-NANO)
One or more human case studies show possible immune effects		OCTISALATE
Limited evidence of skin and immune system toxicity		PROPYLENE GLYCOL
Human skin toxicant - strong evidence		BUTYLPARABEN, PROPYLPARABEN, METHYLPARABEN, ISOBUTYLPARABEN, ETHYLPARABEN, IODOPROPYNYL BUTYLCARBAMATE
Possible human photoallergenic toxicant		OXYBENZONE (BENZOPHENONE-3)
Known human immune system toxicant		FRAGRANCE

Persistence and bioaccumulation*

*This table includes all possible persistence and bioaccumulation concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
Persistent, bioaccumulative in wildlife and humans		MICA
Found to be persistent and bioaccumulative in wildlife		OCTOCRYLENE
Ingredient is suspected or measured to accumulate in people		OCTINOXATE (OCTYL METHOXYCINNAMATE), OXYBENZONE (BENZOPHENONE-3)
Not suspected to be bioaccumulative		TITANIUM DIOXIDE (NON-NANO)

Organ system toxicity (non-reproductive)*

*This table includes all possible organ system toxicity (non-reproductive) concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
One or more animal studies show liver effects at high doses (low dose studies may be unavailable for this ingredient)		OCTINOXATE (OCTYL METHOXYCINNAMATE)
One or more animal studies show liver effects at high doses (low dose studies may be unavailable for this ingredient)		SORBITAN OLEATE, DIHYDROXYACETONE, GLYCINE SOJA (SOYBEAN) OIL, OCTOCRYLENE
One or more animal studies show sense organ effects at moderate doses (low dose studies may be unavailable for this ingredient)	products for use around the eyes, mouth, or lips	PROPYLENE GLYCOL, POLYSORBATE-80
One or more animal studies show metabolic effects at moderate doses (low dose studies may be unavailable for this ingredient)		CALCIUM GLUCONATE,
One or more animal studies show cardiovascular effects at moderate doses (low dose studies may be unavailable for this ingredient)		OXYBENZONE (BENZOPHENONE-3)
One or more animal studies show broad systemic effects at moderate doses (low dose studies may be unavailable for this ingredient)		SOLVENT RED 43, OCTISALATE, MAGNESIUM GLUCONATE, GLYCERYL MONOSTEARATE
Limited evidence of sense organ toxicity		PEG-100 STEARATE, ISOBUTYLPARABEN, ETHYLPARABEN, IODOPROPYNYL BUTYLCARBAMATE, BUTYLPARABEN
Possible human respiratory toxicant		MICA
One or more animal studies show cardiovascular effects at very low doses		TITANIUM DIOXIDE (NON-NANO), GLYCERIN
One or more animal studies show broad systemic effects at low doses		DISODIUM EDTA
One or more animal studies show sense organ effects at very low doses	products for use around the eyes, mouth, or lips	PHENOXYETHANOL
Known human any toxicant		METHYLPARABEN
Limited evidence of sense organ toxicity		PROPYLPARABEN

Miscellaneous*

*This table includes all possible miscellaneous concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
Ingredient not fully labeled - identity unknown		FRAGRANCE

Multiple, additive exposure sources*

*This table includes all possible multiple, additive exposure sources concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
Designated as safe for general or specific, limited use in food		PEG-100 STEARATE, TOCOPHEROL, TITANIUM DIOXIDE (NON-NANO), SORBITAN OLEATE, PROPYLPARABEN, PROPYLENE GLYCOL, POLYSORBATE-80, METHYLPARABEN, MAGNESIUM GLUCONATE, GLYCERYL MONOSTEARATE, GLYCERIN, DISODIUM EDTA, DIMETHICONE, CITRUS MEDICA LIMONUM (LEMON) EXTRACT, CALCIUM GLUCONATE, CARAMEL, BUTYLPARABEN
Used in food or as an additive with limited or no toxicity information available		DIHYDROXYACETONE

Ecotoxicology*

*This table includes all possible ecotoxicology concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
Wildlife and environmental toxicity		PROPYLPARABEN
Wildlife and environmental toxicity		OCTINOXATE (OCTYL METHOXYCINNAMATE), OCTOCRYLENE, OXYBENZONE (BENZOPHENONE-3)
Not suspected to be an environmental toxin		TITANIUM DIOXIDE (NON-NANO)

Irritation (skin, eyes, or lungs)*

*This table includes all possible irritation (skin, eyes, or lungs) concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
Not likely to be a skin irritant in humans		OXYBENZONE (BENZOPHENONE-3)
One or more animal studies show skin irritation at high doses		IODOPROPYNYL BUTYLCARBAMATE
One or more animal studies show skin irritation at moderate doses		TITANIUM DIOXIDE (NON-NANO), SORBITAN OLEATE, GLYCERIN, CALCIUM GLUCONATE, BUTYLPARABEN
One or more animal studies show skin irritation at low doses		OCTISALATE, METHYLPARABEN
One or more animal studies show skin irritation at very low doses		PEG-100 STEARATE
Classified as skin irritant		PROPYLENE GLYCOL, PHENOXYETHANOL

Data gaps*

*This table includes all possible data gaps concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
Safety assessment was based on related chemical		PROPYLENE GLYCOL, ISOBUTYLPARABEN, IODOPROPYNYL BUTYLCARBAMATE, PEG-100 STEARATE
Risk assessment method deficiencies and data gaps - Maximum reported "as used" concentration is basis of safety assessment by industry safety panel (Cosmetic Ingredient Review, CIR) - implicit safe concentration limit in product		TOCOPHEROL, PEG-100 STEARATE, SORBITAN OLEATE, PROPYLPARABEN, PHENOXYETHANOL, POLYSORBATE-80, OXYBENZONE (BENZOPHENONE-3), METHYLPARABEN, DIMETHICONE, GLYCERYL MONOSTEARATE, ETHYLPARABEN, DISODIUM EDTA, BUTYLPARABEN, BEHENYL ALCOHOL
Not assessed for safety in cosmetics by industry panel		SOLVENT RED 43, VITREOSCILLA FERMENT, TRI-C14-15 ALKYL CITRATE, TITANIUM DIOXIDE (NON-NANO), SODIUM POLYACRYLOYLDIMETHYL TAURATE, OCTOCRYLENE, OCTISALATE, MAGNESIUM GLUCONATE, ISOHEXADECANE, GLYCINE SOJA (SOYBEAN) OIL, GLYCERIN, CITRUS MEDICA LIMONUM (LEMON) EXTRACT, FRAGRANCE, CARAMEL, CALCIUM GLUCONATE, C12-15 ALKYL BENZOATE, ARACHIDYL GLUCOSIDE, ARACHIDYL ALCOHOL

Occupational hazards*

*This table includes all possible occupational hazards concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
Allowed workplace exposures restricted to low doses		TITANIUM DIOXIDE (NON-NANO), PHENOXYETHANOL
Allowed workplace exposures restricted to low doses		MICA
Allowed workplace exposures restricted to moderate doses		GLYCERIN

Biochemical or cellular level changes*

*This table includes all possible biochemical or cellular level changes concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
Produces excess reactive oxygen species that can interfere with cellular signaling, cause mutations, lead to cell death and may be implicated in cardiovascular disease.		OCTINOXATE (OCTYL METHOXYCINNAMATE)
One or more animal studies show biochemical changes at very low doses where the human health implications are not yet well understood		TITANIUM DIOXIDE (NON-NANO)
One or more animal studies show biochemical changes at high doses where the human health implications are not yet well understood		GLYCERIN, PROPYLENE GLYCOL
Produces excess reactive oxygen species that can interfere with cellular signaling, cause mutations, lead to cell death and may be implicated in cardiovascular disease.		OCTOCRYLENE
Interferes with gene expresion		BUTYLPARABEN, METHYLPARABEN
Does not produces excess reactive oxygen species or other harmful biochemical changes.		OCTISALATE
Produces excess reactive oxygen species that can interfere with cellular signaling, cause mutations, lead to cell death and may be implicated in cardiovascular disease.		OXYBENZONE (BENZOPHENONE-3)