Sebulex Shampoo with Conditioner (2006 formulation) || Skin Deep: Cosmetic Safety Reviews

SEBULEX SHAMPOO WITH CONDITIONER (2006 FORMULATION)

last updated: 05/01/06 brand: Sebulex by Bristol-Myers Squibb Co.

SCORE

high hazard (out of 10)

75%

data gap

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71% of conditioners have lower concerns
80% of dandruff/scalp treatments have lower concerns
78% of shampoos 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.

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, Persistence and bioaccumulation, Organ system toxicity (non-reproductive), Miscellaneous, Multiple, additive exposure sources, Irritation (skin, eyes, or lungs), Enhanced skin absorption, Contamination concerns

Ingredients from packaging: ACTIVE INGREDIENTS: SULFUR 2%; SALICYLIC ACID 2%. INACTIVE INGREDIENTS: ACETAMIDE MEA; AMPHOTERIC-2; D&C YELLOW #10; DIOCTYL SODIUM SULFOSUCCINATE; DISODIUM EDTA; FD&C BLUE #1; FRAGRANCE; HYDROLYZED ANIMAL PROTEIN; LAURAMIDE DEA; MAGNESIUM ALUMINUM SILICATE; METHYLCELLULOSE; PEG-14 M; PROPYLENE GLYCOL; SODIUM LAURYL SULFATE; SODIUM OCTOXYNOL-2-ETHANE SULFONATE; WATER.

Directions from packaging: Shake well. Shampoo 5 minutes. For optimum dandruff control and conditioning leave shampoo on hair for the full 5 minutes. Rinse. Repeat. Use daily until control is achieved. Use 2-3 times weekly to maintain control, although daily use may be continued. Consult physician for severe or unresponsive scalp conditions.

Warnings from packaging: If undue irritation develops or increases, discontinue use and consult physician. For external use only. Keep out of reach of children. Avoid contact with eyes. In case of contact rinse thoroughly with water.

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ingredients

	score	data gap	concerns
FRAGRANCE	8	100%	Neurotoxicity, Allergies/immunotoxicity, Miscellaneous
SODIUM OCTOXYNOL-2 ETHANE SULFONATE	7	72%	Violations, restrictions & warnings, Allergies/immunotoxicity, Irritation (skin, eyes, or lungs), Contamination concerns (ETHYLENE OXIDE, 1,4-DIOXANE, ETHYLENE OXIDE, 1,4-DIOXANE, C9 PHENOLS)
SALICYLIC ACID (Active Ingredient)	7	66%	Violations, restrictions & warnings, Neurotoxicity, Persistence and bioaccumulation, Organ system toxicity (non-reproductive), Multiple, additive exposure sources, Enhanced skin absorption
PEG-14M	6	76%	Violations, restrictions & warnings, Organ system toxicity (non-reproductive), Contamination concerns (ETHYLENE OXIDE, 1,4-DIOXANE, ETHYLENE OXIDE, 1,4-DIOXANE)
MAGNESIUM ALUMINUM SILICATE	4	88%	Developmental/reproductive toxicity, Neurotoxicity, Organ system toxicity (non-reproductive)
PROPYLENE GLYCOL	4	60%	Allergies/immunotoxicity, Organ system toxicity (non-reproductive), Irritation (skin, eyes, or lungs), Enhanced skin absorption
DISODIUM EDTA	3	78%	Neurotoxicity, Organ system toxicity (non-reproductive), Enhanced skin absorption
D&C YELLOW 10	1	73%	none identified
LAURAMIDE DEA	3	70%	Organ system toxicity (non-reproductive), Irritation (skin, eyes, or lungs), Contamination concerns (NITROSAMINES)
SODIUM LAURYL SULFATE	3	68%	Organ system toxicity (non-reproductive), Irritation (skin, eyes, or lungs)
FD&C BLUE 1	1	83%	none identified
DIOCTYL SODIUM SULFOSUCCINATE	2	81%	Organ system toxicity (non-reproductive), Irritation (skin, eyes, or lungs)
ACETAMIDE MEA	1	73%	Contamination concerns (ACETAMIDE MEA)
AMPHOTERIC-2	1	97%	none identified
HYDROLYZED COLLAGEN HYDROLYZED ANIMAL PROTEIN	0	88%	none identified
METHYLCELLULOSE	1	88%	none identified
SULFUR (Active Ingredient)	1	86%	Organ system toxicity (non-reproductive), Irritation (skin, eyes, or lungs)
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		LAURAMIDE DEA
One or more in vitro tests on mammalian cells show positive mutation results		SODIUM LAURYL SULFATE, PROPYLENE GLYCOL, DISODIUM EDTA
Cancer - not classifiable/not likely to be human carcinogen		SALICYLIC ACID
Cancer - not classifiable/not likely to be human carcinogen		FD&C BLUE 1

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		DIOCTYL SODIUM SULFOSUCCINATE, DISODIUM EDTA, SODIUM LAURYL SULFATE
One or more animal studies show reproductive effects at moderate doses		SALICYLIC ACID, PROPYLENE GLYCOL
Human nervous system toxicant - moderate evidence		MAGNESIUM ALUMINUM SILICATE

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)
Violation of industry recommendations - Restricted in cosmetics; use, concentration, or manufacturing restrictions - Not safe for use on injured or damaged skin	products for use on damaged skin	PEG-14M
Restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions - Japan - restricted for use in cosmetics (concentration limit)		SALICYLIC ACID, SALICYLIC ACID
Recommended restricted in cosmetics - use, concentration, or manufacturing restrictions - Product type restrictions or differences noted in safety assessment by industry panel		SODIUM OCTOXYNOL-2 ETHANE SULFONATE
Determined safe for use in cosmetics, subject to concentration or use limitations - Safe for use in cosmetics with some qualifications		ACETAMIDE MEA, LAURAMIDE DEA, PEG-14M, PROPYLENE GLYCOL, SALICYLIC ACID, SODIUM LAURYL SULFATE, SODIUM OCTOXYNOL-2 ETHANE SULFONATE

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, FD&C BLUE 1
Strong evidence of human neurotoxicity		MAGNESIUM ALUMINUM SILICATE
Moderate evidence of human neurotoxicity		FRAGRANCE
One or more animal studies show brain and nervous system effects at low doses		DISODIUM EDTA, SALICYLIC ACID
One or more animal studies show brain and nervous system effects at moderate doses		DIOCTYL SODIUM SULFOSUCCINATE, SODIUM LAURYL SULFATE

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		DISODIUM EDTA, SODIUM LAURYL SULFATE

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)
Known human immune system toxicant		FRAGRANCE
Limited evidence of skin and immune system toxicity		PROPYLENE GLYCOL
Human skin toxicant - strong evidence		SODIUM OCTOXYNOL-2 ETHANE SULFONATE

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 persistent		SODIUM LAURYL SULFATE
Persistent, bioaccumulative in wildlife		SALICYLIC ACID

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 metabolic effects at high doses (low dose studies may be unavailable for this ingredient)		PROPYLENE GLYCOL
One or more animal studies show broad systemic effects at low doses		SODIUM LAURYL SULFATE, SALICYLIC ACID
Limited evidence of any toxicity		MAGNESIUM ALUMINUM SILICATE, PEG-14M
One or more animal studies show blood effects at moderate doses (low dose studies may be unavailable for this ingredient)		LAURAMIDE DEA, METHYLCELLULOSE,
One or more animal studies show classified as toxic effects at moderate doses (low dose studies may be unavailable for this ingredient)		FD&C BLUE 1
One or more animal studies show broad systemic effects at high doses (low dose studies may be unavailable for this ingredient)		ACETAMIDE MEA, D&C YELLOW 10
One or more animal studies show broad systemic effects at low doses		DISODIUM EDTA, DIOCTYL SODIUM SULFOSUCCINATE
One or more animal studies show broad systemic effects at very low doses		SULFUR

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		SODIUM LAURYL SULFATE, SALICYLIC ACID, PROPYLENE GLYCOL, PEG-14M, METHYLCELLULOSE, LAURAMIDE DEA, FD&C BLUE 1, DISODIUM EDTA, DIOCTYL SODIUM SULFOSUCCINATE
Used in food or as an additive with limited or no toxicity information available		SALICYLIC ACID

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		SODIUM LAURYL SULFATE

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		SALICYLIC ACID, AMPHOTERIC-2, ACETAMIDE MEA
One or more animal studies show skin irritation at low doses		DIOCTYL SODIUM SULFOSUCCINATE
One or more animal studies show skin irritation at very low doses		LAURAMIDE DEA
Human any irritant - strong evidence	products for use around the eyes, on the skin, or may be aerosolized (airborne)	SODIUM OCTOXYNOL-2 ETHANE SULFONATE, SODIUM LAURYL SULFATE
Classified as skin irritant		PROPYLENE GLYCOL, SULFUR

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
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		METHYLCELLULOSE
Safety assessment was based on related chemical		SODIUM OCTOXYNOL-2 ETHANE SULFONATE
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		LAURAMIDE DEA, HYDROLYZED COLLAGEN, MAGNESIUM ALUMINUM SILICATE, DISODIUM EDTA
Not assessed for safety in cosmetics by industry panel		FRAGRANCE, SULFUR
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		DIOCTYL SODIUM SULFOSUCCINATE
Not assessed for safety in cosmetics by industry panel		AMPHOTERIC-2

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 high doses where the human health implications are not yet well understood		DIOCTYL SODIUM SULFOSUCCINATE, PROPYLENE GLYCOL
One or more animal studies show biochemical changes at moderate doses where the human health implications are not yet well understood		SODIUM LAURYL SULFATE, LAURAMIDE DEA