Fallene Total Block Dries Clear, SPF 65 || Skin Deep: Cosmetic Safety Reviews

FALLENE TOTAL BLOCK DRIES CLEAR, SPF 65

last updated: 04/01/08 brand: Fallene by Fallene, Ltd.

SCORE

	health hazard
	sun hazard

81%

data gap

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63% 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
4	UVA hazard/exposure score
1	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 (4%)

NANO ZINC OXIDE (20-60nm) (5%)

OCTOCRYLENE (7%)

OCTINOXATE (OCTYL METHOXYCINNAMATE) (6%)

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: Neurotoxicity, Endocrine disruption, Persistence and bioaccumulation, Organ system toxicity (non-reproductive), 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 4%, Zinc Oxide 5%, Benzophenone 4%, Octocrylene 7%, Octinoxate 6%. Inactive Ingredients: Acrylate/octylepropenamide copolymer, aluminum starch octenylsuccinate, ascorbyl palmitate, 5-bromo-nitro-1, 3-dioxane (and) propylene glycol, caramel carotene, cetearyl alcohol (and) cetearyl polyglucose, dimethicone, disodium EDTA, iron oxides, isopropyl paraben (and) isobutylparaben (and) butylparaben, linoleamidopropyl dimethylamine, Pycnogenol (maritime pine extract), octyldodecyl neopentanoate, polysorbate 20, propelene glycol, purified water, seleniumyeast derivative, simethicone, sorbitan laurate, talc, tocopherol, tocopheryl acetate.

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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
ALUMINUM STARCH OCTENYLSUCCINATE	9	74%	Developmental/reproductive toxicity, Neurotoxicity, Organ system toxicity (non-reproductive), Contamination concerns (ARSENIC, LEAD, HEAVY METALS)
NANO ZINC OXIDE (20-60nm) (Active Ingredient)	3	70%	Violations, restrictions & warnings, Persistence and bioaccumulation, Organ system toxicity (non-reproductive), Occupational hazards
SACCHARAMYCES/ SELENIUM FERMENT EXTRACT SELENIUMYEAST DERIVATIVE	9	65%	Cancer, Developmental/reproductive toxicity, Violations, restrictions & warnings, Neurotoxicity, Organ system toxicity (non-reproductive), Occupational hazards
OCTINOXATE (OCTYL METHOXYCINNAMATE) (Active Ingredient)	8	65%	Violations, restrictions & warnings, Endocrine disruption, Allergies/immunotoxicity, Persistence and bioaccumulation, Enhanced skin absorption, Biochemical or cellular level changes
5-BROMO-5-NITRO-1,3 DIOXANE 5-BROMO-NITRO-1 3-DIOXANE	8	62%	Violations, restrictions & warnings, Neurotoxicity, Allergies/immunotoxicity, Contamination concerns (FORMALDEHYDE, NITROSAMINES)
BUTYLPARABEN	6	79%	Developmental/reproductive toxicity, Endocrine disruption, Allergies/immunotoxicity, Organ system toxicity (non-reproductive), Biochemical or cellular level changes
TOCOPHERYL ACETATE	4	81%	Allergies/immunotoxicity, Contamination concerns (HYDROQUINONE)
PROPYLENE GLYCOL	4	60%	Allergies/immunotoxicity, Organ system toxicity (non-reproductive), Irritation (skin, eyes, or lungs), Enhanced skin absorption
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)
DISODIUM EDTA	3	78%	Neurotoxicity, Organ system toxicity (non-reproductive), Enhanced skin absorption
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)
IRON OXIDES	2	85%	Persistence and bioaccumulation, Enhanced skin absorption
BENZOPHENONE (Active Ingredient)	2	79%	Endocrine disruption, Organ system toxicity (non-reproductive)
CETEARYL ALCOHOL	0	93%	none identified
CARAMEL	1	92%	none identified
ASCORBYL PALMITATE (VITAMIN C PALMITATE)	1	88%	none identified
POLYSORBATE-20	1	84%	none identified
ACRYLATES/ OCTYLPROPENAMIDE COPOLYMER ACRYLATE/OCTYLEPROPENAMIDE COPOLYMER	0	100%	none identified
CETEARYL GLUCOSIDE CETEARYL POLYGLUCOSE	0	100%	none identified
LINOLEAMIDOPROPYL DIMETHYLAMINE	0	100%	none identified
OCTYLDODECYL NEOPENTANOATE	0	100%	none identified
PYCNOGENOL	0	100%	none identified
SIMETHICONE	0	100%	none identified
CAROTENE	0	100%	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 in vitro tests on mammalian cells show positive mutation results		NANO TITANIUM DIOXIDE, NANO ZINC OXIDE (20-60nm)
One or more in vitro tests on mammalian cells show positive mutation results		TOCOPHERYL ACETATE, TOCOPHEROL, PROPYLENE GLYCOL, DISODIUM EDTA, CARAMEL, BUTYLPARABEN, BENZOPHENONE
Cancer - limited evidence		SACCHARAMYCES/ SELENIUM FERMENT EXTRACT

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		POLYSORBATE-20, DISODIUM EDTA,
One or more animal studies show developmental effects at high doses		NANO ZINC OXIDE (20-60nm)
One or more animal studies show reproductive effects at high doses		BENZOPHENONE
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
One or more animal studies show any effects at very low doses		BUTYLPARABEN
Human nervous system toxicant - moderate evidence		ALUMINUM STARCH OCTENYLSUCCINATE, SACCHARAMYCES/ SELENIUM FERMENT EXTRACT

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		5-BROMO-5-NITRO-1,3 DIOXANE, ALUMINUM STARCH OCTENYLSUCCINATE, PROPYLENE GLYCOL
Restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions - Use is restricted in Canadian cosmetics		5-BROMO-5-NITRO-1,3 DIOXANE
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 cosmetics (concentration limit)		OCTOCRYLENE, NANO ZINC OXIDE (20-60nm)
Violation of government restrictions - Banned or found unsafe for use in cosmetics		SACCHARAMYCES/ SELENIUM FERMENT EXTRACT

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
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 high doses		NANO ZINC OXIDE (20-60nm)
One or more animal studies show brain and nervous system effects at moderate doses		BENZOPHENONE
One or more animal studies show brain and nervous system effects at low doses		5-BROMO-5-NITRO-1,3 DIOXANE
Strong evidence of human neurotoxicity		ALUMINUM STARCH OCTENYLSUCCINATE, SACCHARAMYCES/ SELENIUM FERMENT EXTRACT

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 disruption at moderate doses		ISOBUTYLPARABEN
One or more studies show weak endocrine disruption		ISOPROPYLPARABEN
One or more animal studies show endocrine system disruption at high doses		DISODIUM EDTA
Limited evidence of endocrine disruption		BENZOPHENONE
Human any disruptor - strong evidence		OCTINOXATE (OCTYL METHOXYCINNAMATE), 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
Known human immune system toxicant		5-BROMO-5-NITRO-1,3 DIOXANE
Human skin toxicant - strong evidence		BUTYLPARABEN, ISOBUTYLPARABEN, ISOPROPYLPARABEN, TOCOPHERYL ACETATE
Limited evidence of skin and immune system toxicity		PROPYLENE GLYCOL
One or more human case studies show possible photoallergic effects		OCTINOXATE (OCTYL METHOXYCINNAMATE)

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, TALC
Ingredient is suspected or measured to accumulate in people		OCTINOXATE (OCTYL METHOXYCINNAMATE)
Found to be persistent and bioaccumulative in wildlife		OCTOCRYLENE
Persistent, bioaccumulative in wildlife		NANO ZINC OXIDE (20-60nm)
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 high doses (low dose studies may be unavailable for this ingredient)		ASCORBYL PALMITATE (VITAMIN C PALMITATE), POLYSORBATE-20, 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
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)		OCTINOXATE (OCTYL METHOXYCINNAMATE)
Limited evidence of sense organ toxicity		ISOPROPYLPARABEN
One or more animal studies show broad systemic effects at moderate doses (low dose studies may be unavailable for this ingredient)		TOCOPHERYL ACETATE,
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)
Limited evidence of sense organ toxicity		ISOBUTYLPARABEN, BUTYLPARABEN, BENZOPHENONE, ALUMINUM STARCH OCTENYLSUCCINATE
One or more animal studies show broad systemic effects at low doses		DISODIUM EDTA
One or more animal studies show cardiovascular effects at very low doses		NANO TITANIUM DIOXIDE
Known human respiratory toxicant		SACCHARAMYCES/ SELENIUM FERMENT 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)
Not suspected to be an environmental toxin		TALC
Wildlife and environmental toxicity		OCTOCRYLENE, OCTINOXATE (OCTYL METHOXYCINNAMATE)
Wildlife and environmental toxicity		NANO TITANIUM DIOXIDE
Wildlife and environmental toxicity		SACCHARAMYCES/ SELENIUM FERMENT EXTRACT, NANO ZINC OXIDE (20-60nm)

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 high doses		BENZOPHENONE
One or more animal studies show skin irritation at moderate doses		TALC, POLYSORBATE-20, NANO ZINC OXIDE (20-60nm), BUTYLPARABEN, 5-BROMO-5-NITRO-1,3 DIOXANE
One or more animal studies show significant but moderate pulmonary irritation at low doses		NANO TITANIUM DIOXIDE
Classified as skin irritant		PROPYLENE GLYCOL

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, ISOPROPYLPARABEN
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		TOCOPHERYL ACETATE, POLYSORBATE-20, TOCOPHEROL
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		SORBITAN LAURATE, DISODIUM EDTA, DIMETHICONE, CETEARYL ALCOHOL, BUTYLPARABEN
Not assessed for safety in cosmetics by industry panel		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		ASCORBYL PALMITATE (VITAMIN C PALMITATE)
Not assessed for safety in cosmetics by industry panel		CAROTENE, TALC, SIMETHICONE, SACCHARAMYCES/ SELENIUM FERMENT EXTRACT, PYCNOGENOL, OCTYLDODECYL NEOPENTANOATE, OCTOCRYLENE, NANO ZINC OXIDE (20-60nm), LINOLEAMIDOPROPYL DIMETHYLAMINE, CETEARYL GLUCOSIDE, CARAMEL, BENZOPHENONE, ACRYLATES/ OCTYLPROPENAMIDE COPOLYMER

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		TALC, NANO ZINC OXIDE (20-60nm),
Allowed workplace exposures restricted to low doses		NANO TITANIUM DIOXIDE, SACCHARAMYCES/ SELENIUM FERMENT EXTRACT

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)
One or more animal studies show biochemical changes at moderate doses where the human health implications are not yet well understood		BENZOPHENONE
One or more animal studies show blood sugar changes at high doses where the human health implications are not yet well understood		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.		OCTINOXATE (OCTYL METHOXYCINNAMATE), OCTOCRYLENE
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