Nucelle Sunsense Sunscreen, SPF 30+ (2007 formulation) || Skin Deep: Cosmetic Safety Reviews

NUCELLE SUNSENSE SUNSCREEN, SPF 30+ (2007 FORMULATION)

last updated: 09/04/07 brand: NuCelle by NuCelle Inc.

SCORE

	health hazard
	sun hazard

81%

data gap

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7% of sunscreen: SPF 15-30s have lower concerns

COMPANY POLICIES

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

Animal Testing Policy
This company does not test on animals.

Sunscreen effectiveness* breakdown

0	UVB hazard/exposure score
4	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

OCTINOXATE (OCTYL METHOXYCINNAMATE) (7.5%)

NANO ZINC OXIDE (20-60nm) (6.8%)

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), 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: Actives: Octinoxate; Zinc Oxide; Inactives: Water; Aloe Barbadensis Leaf Extract; Cyclomethicone; Diisopropyl Adipate; Synthetic Beeswax; Hexylene Glycol; Carnauba Wax; PEG40 Stearate; Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer; Vitamin E Acetate; Vitamin A Palmitate; Squalane; C12-15 Alkyl Benzoate; Dimethicone Copolyol Beeswax; Dipropylene Glycol Dibenzoate; Isododecane; Dimethicone; Stearyl Alcohol; Stearoxytrimethylsilane; Glyceryl Stearate; PEG 100 Stearate; Cetearyl Alcohol; Silica; PPG-15 Stearyl Ether Benzoate; Sorbitan Tristearate; Steareth-100; Triethoxycaprylysilane; PVP/Eicosene Copolymer; Caprylyl Glycol; DEA-Oleth-3 Phosphate; Polysorbate 60; Triethanolimine; Methylisothiazolinone

Directions from packaging: Apply four to six pumps to face and neck. Allow to dry, then apply moisturizer and/or makeup, as desired.

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ingredients

	score	data gap	concerns
NANO ZINC OXIDE (20-60nm) (Active Ingredient)	3	70%	Violations, restrictions & warnings, Persistence and bioaccumulation, Organ system toxicity (non-reproductive), Occupational hazards
OCTINOXATE (OCTYL METHOXYCINNAMATE) (Active Ingredient)	6	65%	Endocrine disruption, Allergies/immunotoxicity, Persistence and bioaccumulation, Enhanced skin absorption, Biochemical or cellular level changes
PEG-40 STEARATE	4	70%	Organ system toxicity (non-reproductive), Irritation (skin, eyes, or lungs), Contamination concerns (ETHYLENE OXIDE, 1,4-DIOXANE, ETHYLENE OXIDE, 1,4-DIOXANE)
SILICA	1	69%	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)
METHYLISOTHIAZOLINONE	6	63%	Violations, restrictions & warnings, Allergies/immunotoxicity
TRIETHANOLAMINE TRIETHANOLIMINE	6	58%	Allergies/immunotoxicity, Organ system toxicity (non-reproductive), Irritation (skin, eyes, or lungs), Contamination concerns (NITROSAMINES), Occupational hazards
RETINYL PALMITATE VITAMIN A PALMITATE	5	68%	Cancer, Developmental/reproductive toxicity, Violations, restrictions & warnings, Organ system toxicity (non-reproductive), Biochemical or cellular level changes
HEXYLENE GLYCOL	4	67%	Allergies/immunotoxicity, Irritation (skin, eyes, or lungs)
TOCOPHERYL ACETATE VITAMIN E ACETATE	4	81%	Allergies/immunotoxicity, Contamination concerns (HYDROQUINONE)
DEA-OLETH-3 PHOSPHATE	3	94%	Contamination concerns (ETHYLENE OXIDE, 1,4-DIOXANE)
DIMETHICONE	2	74%	Violations, restrictions & warnings
CYCLOMETHICONE	2	83%	Persistence and bioaccumulation, Organ system toxicity (non-reproductive)
C12-15 ALKYL BENZOATE	0	94%	none identified
DIPROPYLENE GLYCOL DIBENZOATE	1	94%	Organ system toxicity (non-reproductive)
STEAROXYTRIMETHYLSILANE	0	94%	none identified
CETEARYL ALCOHOL	0	93%	none identified
SQUALANE	1	93%	Irritation (skin, eyes, or lungs)
STEARETH-100	1	89%	none identified
GLYCERYL MONOSTEARATE GLYCERYL STEARATE	1	88%	none identified
DIISOPROPYL ADIPATE	1	87%	none identified
SYNTHETIC BEESWAX	1	87%	Irritation (skin, eyes, or lungs)
STEARYL ALCOHOL	1	84%	Irritation (skin, eyes, or lungs)
POLYSORBATE-60	1	81%	none identified
ALOE BARBADENSIS (ALOE VERA) LEAF EXTRACT ALOE BARBADENSIS LEAF EXTRACT	1	75%	none identified
HYDROXYETHYL ACRYLATE/ SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER	0	100%	none identified
ISODODECANE	0	100%	none identified
PPG-15 STEARYL ETHER BENZOATE	0	100%	none identified
TRIETHOXYCAPRYLYLSILANE TRIETHOXYCAPRYLYSILANE	0	100%	none identified
CAPRYLYL GLYCOL	0	94%	none identified
VP/ EICOSENE COPOLYMER	0	94%	none identified
BEESWAX	0	93%	none identified
COPERNICIA CERIFERA (CARNAUBA) WAX	0	93%	none identified
SORBITAN TRISTEARATE	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 high doses		STEARYL ALCOHOL, POLYSORBATE-60
One or more animal studies show tumor formation at moderate doses		PEG-100 STEARATE, PEG-40 STEARATE
One or more in vitro tests on mammalian cells show positive mutation results		NANO ZINC OXIDE (20-60nm)
One or more in vitro tests on mammalian cells show positive mutation results		TOCOPHERYL ACETATE
Cancer - limited evidence		RETINYL PALMITATE
Cancer - not classifiable/not likely to be human carcinogen		TRIETHANOLAMINE

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, POLYSORBATE-60, PEG-40 STEARATE,
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 moderate doses		OCTINOXATE (OCTYL METHOXYCINNAMATE)
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		TRIETHANOLAMINE, PEG-100 STEARATE, ALOE BARBADENSIS (ALOE VERA) LEAF EXTRACT, METHYLISOTHIAZOLINONE, PEG-40 STEARATE
Restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions - Japan - concentration limit in some types of cosmetics when combined with certain other ingredient(s)		METHYLISOTHIAZOLINONE
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		METHYLISOTHIAZOLINONE, RETINYL PALMITATE, NANO ZINC OXIDE (20-60nm)

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 in vitro tests on mammalian cells demonstrate neurotoxicity		METHYLISOTHIAZOLINONE
nervous system - weight of evidence unknown/unassessed/unreview: published lit review or major tox study		HEXYLENE GLYCOL
One or more animal studies show brain and nervous system effects at high doses		RETINYL PALMITATE, NANO ZINC OXIDE (20-60nm)

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		TRIETHANOLAMINE, HEXYLENE GLYCOL
Human any disruptor - strong evidence		OCTINOXATE (OCTYL METHOXYCINNAMATE)

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)
One or more human case studies show possible photoallergic effects		OCTINOXATE (OCTYL METHOXYCINNAMATE)
Human skin toxicant - strong evidence		TOCOPHERYL ACETATE
Known human immune system toxicant		TRIETHANOLAMINE, METHYLISOTHIAZOLINONE, HEXYLENE GLYCOL

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		TRIETHANOLAMINE
Not suspected to be persistent		DIPROPYLENE GLYCOL DIBENZOATE
Ingredient is suspected or measured to accumulate in people		OCTINOXATE (OCTYL METHOXYCINNAMATE)
Persistent, bioaccumulative in wildlife		NANO ZINC OXIDE (20-60nm), CYCLOMETHICONE

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)
Classified as expected to be toxic or harmful		DIPROPYLENE GLYCOL DIBENZOATE
One or more animal studies show metabolic effects at high doses (low dose studies may be unavailable for this ingredient)		SILICA,
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)		HEXYLENE GLYCOL, CYCLOMETHICONE, SYNTHETIC BEESWAX, STEARYL ALCOHOL
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)		STEARETH-100, TOCOPHERYL ACETATE, POLYSORBATE-60, GLYCERYL MONOSTEARATE, DIISOPROPYL ADIPATE
Limited evidence of skin toxicity		RETINYL PALMITATE, PEG-100 STEARATE, PEG-40 STEARATE
Possible human immune system toxicant		TRIETHANOLAMINE

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		DIPROPYLENE GLYCOL DIBENZOATE, CYCLOMETHICONE
Not suspected to be an environmental toxin		TRIETHANOLAMINE
Wildlife and environmental toxicity		OCTINOXATE (OCTYL METHOXYCINNAMATE)
Wildlife and environmental toxicity		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 moderate doses		NANO ZINC OXIDE (20-60nm), DIISOPROPYL ADIPATE, CYCLOMETHICONE
One or more animal studies show skin irritation at low doses		SYNTHETIC BEESWAX, SQUALANE
One or more animal studies show skin irritation at very low doses		PEG-100 STEARATE, TRIETHANOLAMINE, PEG-40 STEARATE
Human any irritant - strong evidence	products for use around the eyes, on the skin, or may be aerosolized (airborne)	STEARYL ALCOHOL
Classified as irritant		HEXYLENE 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)
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
Insufficient data to determine safety		NANO ZINC OXIDE (20-60nm)
Safety assessment was based on related chemical		PEG-40 STEARATE
Missing safety data noted by cosmetic industry review		ALOE BARBADENSIS (ALOE VERA) LEAF EXTRACT
Safety assessment was based on related chemical		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		PEG-100 STEARATE, SYNTHETIC BEESWAX, SORBITAN TRISTEARATE, STEARYL ALCOHOL, RETINYL PALMITATE, HEXYLENE GLYCOL, POLYSORBATE-60, GLYCERYL MONOSTEARATE, PEG-40 STEARATE, DIMETHICONE, CETEARYL ALCOHOL, DIISOPROPYL ADIPATE, CYCLOMETHICONE, COPERNICIA CERIFERA (CARNAUBA) WAX, BEESWAX
Not assessed for safety in cosmetics by industry panel		STEARETH-100, TRIETHOXYCAPRYLYLSILANE, STEAROXYTRIMETHYLSILANE, SQUALANE, VP/ EICOSENE COPOLYMER, PPG-15 STEARYL ETHER BENZOATE, NANO ZINC OXIDE (20-60nm), ISODODECANE, HYDROXYETHYL ACRYLATE/ SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, DIPROPYLENE GLYCOL DIBENZOATE, DEA-OLETH-3 PHOSPHATE, CAPRYLYL GLYCOL, C12-15 ALKYL BENZOATE

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 moderate doses		TRIETHANOLAMINE
Allowed workplace exposures restricted to low doses		NANO ZINC OXIDE (20-60nm)

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 very low doses where the human health implications are not yet well understood		SILICA
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, OCTINOXATE (OCTYL METHOXYCINNAMATE)