Fallene Cotz Sunscreen, SPF 58 || Skin Deep: Cosmetic Safety Reviews

FALLENE COTZ SUNSCREEN, SPF 58

last updated: 04/03/08 brand: Fallene by Fallene, Ltd.

SCORE

	health hazard
	sun hazard

83%

data gap

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7% of sunscreen: SPF greater than 30s have lower concerns

COMPANY POLICIES

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

Animal Testing Policy
This company's animal testing policy is unknown.

Sunscreen effectiveness* breakdown

0	UVB hazard/exposure score
3	UVA hazard/exposure score
0	sunscreen instability

*Note that the same active ingredient combination may score differently in two different products depending on the concentration of the ingredients and the mixture of inactive ingredients.

Active ingredient UV
blocking strength

Product total

NANO TITANIUM DIOXIDE (10%)

NANO ZINC OXIDE (20-60nm) (3%)

Note to manufacturers: We have assumed a typical particle size for the mineral(s) in your product based on typical industry use. We welcome specific data from manufacturers if actual particle size is different.

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: Endocrine disruption, Persistence and bioaccumulation, Organ system toxicity (non-reproductive), Multiple, additive exposure sources, Irritation (skin, eyes, or lungs), Enhanced skin absorption, Contamination concerns, Occupational hazards, Biochemical or cellular level changes

Note from EWG: Unlike many other kinds of personal care products, sunscreen can provide health benefits, protecting against the sun's cancer-causing UV radiation. More than one million cases of skin cancer are diagnosed in the U.S. every year. Health officials recommend wearing sunscreen as one of many important steps to minimize skin cancer risk. (more sun safety tips)

Ingredients from packaging: Active Ingredients: Titanium Dioxide, Zinc Oxide. Inactive Ingredients: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Butyloctyl Salicylate, Butylene Glycol, Butylparaben, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cyclomethicone, Dimethicone EDTA, Ethylhexyl Hydroxystearate Benzoate, Glyceryl Stearate, Iron Oxides, Isobutylparaben, Isopropylparaben, Melissa Officinalis (Balm Mint) Leaf Extract, Octyldodecyl Neopentanoate, PEG-100 Stearate, Phenoxyethanol, PVP/Eicosene Copolymer, Retinyl Palmitate, Simethicone, Sorbitan Laurate, Styrene/Acrylates Copolymer, Talc, Tocopherol, Tocopheryl Acetate, Water (Aqua), Xanthan Gum.

Directions from packaging: Apply a thin even layer to exposed skin areas 15 minutes prior to exposure. Reapply every 3-4 hours or after excessive sweating or swimming.

Warnings from packaging: External use only. Avoid contact with eyes. Rinse eyes thoroughly if contact occurs. If skin irritation or sensitivity occurs, discontinue use. Keep this and all medications out of reach of children.

user reviews & comments

snstvskn

"This was an effective sports sun block; one would definitely not burn. It is lightly tinted and I was hoping I could use it as a daily foundation, bu ..."

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ingredients

	score	data gap	concerns
NANO TITANIUM DIOXIDE (Active Ingredient)	2	87%	Organ system toxicity (non-reproductive), Irritation (skin, eyes, or lungs), Occupational hazards, Biochemical or cellular level changes
NANO ZINC OXIDE (20-60nm) (Active Ingredient)	3	70%	Violations, restrictions & warnings, Persistence and bioaccumulation, Organ system toxicity (non-reproductive), Occupational hazards
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
RETINYL PALMITATE	5	68%	Cancer, Developmental/reproductive toxicity, Violations, restrictions & warnings, Organ system toxicity (non-reproductive), Biochemical or cellular level changes
TOCOPHERYL ACETATE	4	81%	Allergies/immunotoxicity, Contamination concerns (HYDROQUINONE)
PHENOXYETHANOL	4	67%	Violations, restrictions & warnings, Allergies/immunotoxicity, Irritation (skin, eyes, or lungs), Occupational hazards
TALC	3	86%	Organ system toxicity (non-reproductive), Contamination concerns (ASBESTIFORM FIBERS), Occupational hazards
ISOPROPYLPARABEN	3	84%	Allergies/immunotoxicity, Organ system toxicity (non-reproductive)
ISOBUTYLPARABEN	3	83%	Allergies/immunotoxicity, Organ system toxicity (non-reproductive)
EDTA	3	78%	Organ system toxicity (non-reproductive), Irritation (skin, eyes, or lungs), Enhanced skin absorption
STYRENE/ ACRYLATES COPOLYMER	3	75%	Contamination concerns (METHACRYLIC ACID, ACRYLIC ACID, 2-ETHYLHEXYL ACRYLATE)
DIMETHICONE	2	74%	Violations, restrictions & warnings
TOCOPHEROL	2	87%	Contamination concerns (HYDROQUINONE)
IRON OXIDES	2	85%	Persistence and bioaccumulation, Enhanced skin absorption
CYCLOMETHICONE	2	83%	Persistence and bioaccumulation, Organ system toxicity (non-reproductive)
MELISSA OFFICINALIS (LEMON BALM) LEAF EXTRACT MELISSA OFFICINALIS (BALM MINT) LEAF EXTRACT	1	100%	Multiple, additive exposure sources
CAPRYLIC/ CAPRIC TRIGLYCERIDE	0	94%	none identified
CETEARYL ALCOHOL	0	93%	none identified
GLYCERYL MONOSTEARATE GLYCERYL STEARATE	1	88%	none identified
BUTYLENE GLYCOL	1	79%	Irritation (skin, eyes, or lungs)
BUTYLOCTYL SALICYLATE	1	76%	none identified
ACRYLATES/ C10-30 ALKYL ACRYLATE CROSSPOLYMER	0	100%	none identified
CETEARYL GLUCOSIDE	0	100%	none identified
ETHYLHEXYL HYDROXYSTEARATE BENZOATE	0	100%	none identified
OCTYLDODECYL NEOPENTANOATE	0	100%	none identified
SIMETHICONE	0	100%	none identified
VP/ EICOSENE COPOLYMER	0	94%	none identified
XANTHAN GUM	0	94%	none identified
SORBITAN LAURATE	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 animal studies show tumor formation at moderate doses		PEG-100 STEARATE
One or more in vitro tests non-mammalian cells show positive mutation results		PHENOXYETHANOL
One or more in vitro tests on mammalian cells show positive mutation results		NANO ZINC OXIDE (20-60nm), NANO TITANIUM DIOXIDE
One or more in vitro tests on mammalian cells show positive mutation results		TOCOPHERYL ACETATE, TOCOPHEROL, EDTA, BUTYLPARABEN
Cancer - limited evidence		RETINYL PALMITATE

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		BUTYLENE GLYCOL, PEG-100 STEARATE, EDTA,
One or more animal studies show developmental effects at high doses		NANO ZINC OXIDE (20-60nm)
One or more animal studies show any effects at very low doses		BUTYLPARABEN
One or more animal studies show reproductive effects at low doses		RETINYL PALMITATE

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		BUTYLOCTYL SALICYLATE, STYRENE/ ACRYLATES COPOLYMER, PEG-100 STEARATE
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 - Use is restricted in Canadian cosmetics		RETINYL PALMITATE, NANO ZINC OXIDE (20-60nm), PHENOXYETHANOL

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		RETINYL PALMITATE, NANO ZINC OXIDE (20-60nm), BUTYLENE GLYCOL
One or more animal studies show brain and nervous system effects at moderate doses		PHENOXYETHANOL, EDTA

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		BUTYLENE GLYCOL
One or more studies show weak endocrine disruption		ISOPROPYLPARABEN
One or more animal studies show endocrine disruption at moderate doses		ISOBUTYLPARABEN
Human any disruptor - strong evidence		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)
respiratory - weight of evidence unknown/unassessed/unreview: published lit review or major tox study		NANO TITANIUM DIOXIDE
Limited evidence of skin and immune system toxicity		PHENOXYETHANOL
Human skin toxicant - strong evidence		ISOBUTYLPARABEN, ISOPROPYLPARABEN, TOCOPHERYL ACETATE, BUTYLPARABEN

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)
Not suspected to be bioaccumulative		NANO TITANIUM DIOXIDE
Persistent, bioaccumulative in wildlife		NANO ZINC OXIDE (20-60nm)
Not suspected to be bioaccumulative		TALC, EDTA
Persistent, bioaccumulative in wildlife		CYCLOMETHICONE
Persistent, bioaccumulative in wildlife and humans		IRON OXIDES

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 broad systemic effects at moderate doses (low dose studies may be unavailable for this ingredient)		TOCOPHERYL ACETATE
Classified as expected to be toxic or harmful		TALC
One or more animal studies show liver effects at high doses (low dose studies may be unavailable for this ingredient)		CYCLOMETHICONE, BUTYLENE GLYCOL
One or more animal studies show gastrointestinal effects at moderate doses (low dose studies may be unavailable for this ingredient)		PHENOXYETHANOL,
One or more animal studies show classified as toxic effects at moderate doses (low dose studies may be unavailable for this ingredient)		NANO ZINC OXIDE (20-60nm)
One or more animal studies show broad systemic effects at moderate doses (low dose studies may be unavailable for this ingredient)		GLYCERYL MONOSTEARATE
Limited evidence of sense organ toxicity		ISOPROPYLPARABEN, PEG-100 STEARATE, RETINYL PALMITATE, ISOBUTYLPARABEN, BUTYLPARABEN
One or more animal studies show broad systemic effects at low doses		EDTA
One or more animal studies show cardiovascular effects at very low doses		NANO TITANIUM DIOXIDE

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		NANO TITANIUM DIOXIDE, PEG-100 STEARATE, XANTHAN GUM, TOCOPHERYL ACETATE, TOCOPHEROL, TALC, IRON OXIDES, RETINYL PALMITATE, NANO ZINC OXIDE (20-60nm), GLYCERYL MONOSTEARATE, DIMETHICONE, BUTYLPARABEN, BUTYLENE GLYCOL
Used in food or as an additive with limited or no toxicity information available		MELISSA OFFICINALIS (LEMON BALM) LEAF EXTRACT

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)
Suspected to be an environmental toxin		CYCLOMETHICONE
Not suspected to be an environmental toxin		TALC, EDTA
Wildlife and environmental toxicity		NANO ZINC OXIDE (20-60nm)
Wildlife and environmental toxicity		NANO TITANIUM DIOXIDE

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)
One or more animal studies show skin irritation at moderate doses		TALC, BUTYLPARABEN, NANO ZINC OXIDE (20-60nm), CYCLOMETHICONE
One or more animal studies show significant but moderate pulmonary irritation at low doses		NANO TITANIUM DIOXIDE
One or more animal studies show skin irritation at very low doses		PEG-100 STEARATE
Human any irritant - strong evidence	products for use around the eyes, on the skin, or may be aerosolized (airborne)	BUTYLENE GLYCOL
Classified as irritant		PHENOXYETHANOL, EDTA

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		ISOPROPYLPARABEN, PEG-100 STEARATE
Considered safe based on assumption of low absorption		STYRENE/ ACRYLATES COPOLYMER
Insufficient data to determine safety		NANO ZINC OXIDE (20-60nm)
Safety assessment was based on related chemical		ISOBUTYLPARABEN
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, TOCOPHERYL ACETATE, PEG-100 STEARATE, SORBITAN LAURATE, RETINYL PALMITATE, GLYCERYL MONOSTEARATE, PHENOXYETHANOL, EDTA, DIMETHICONE, BUTYLPARABEN, CETEARYL ALCOHOL, CYCLOMETHICONE
Not assessed for safety in cosmetics by industry panel		TALC, XANTHAN GUM, NANO TITANIUM DIOXIDE
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		BUTYLENE GLYCOL
Not assessed for safety in cosmetics by industry panel		SIMETHICONE, VP/ EICOSENE COPOLYMER, OCTYLDODECYL NEOPENTANOATE, NANO ZINC OXIDE (20-60nm), MELISSA OFFICINALIS (LEMON BALM) LEAF EXTRACT, ETHYLHEXYL HYDROXYSTEARATE BENZOATE, CETEARYL GLUCOSIDE, CAPRYLIC/ CAPRIC TRIGLYCERIDE, ACRYLATES/ C10-30 ALKYL ACRYLATE CROSSPOLYMER

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		PHENOXYETHANOL
Allowed workplace exposures restricted to low doses		NANO ZINC OXIDE (20-60nm), TALC,
Allowed workplace exposures restricted to low doses		NANO TITANIUM DIOXIDE

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)
Interferes with gene expresion		BUTYLPARABEN
One or more animal studies show biochemical changes at very low doses where the human health implications are not yet well understood		NANO TITANIUM DIOXIDE
One or more animal studies show biochemical changes at high doses where the human health implications are not yet well understood		CYCLOMETHICONE
Produces excess reactive oxygen species that can interfere with cellular signaling, cause mutations, lead to cell death and may be implicated in cardiovascular disease.		RETINYL PALMITATE