Soothe XP Extra Protection Emollient Eye Drops || Skin Deep: Cosmetic Safety Reviews

SOOTHE XP EXTRA PROTECTION EMOLLIENT EYE DROPS

last updated: 10/01/09 brand: by

SCORE

moderate hazard (out of 10)

66%

data gap

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80% of eye drops/artificial tears for contacts 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, Endocrine disruption, Organ system toxicity (non-reproductive), Multiple, additive exposure sources, Irritation (skin, eyes, or lungs), Enhanced skin absorption, Contamination concerns, Occupational hazards

Ingredients from packaging: Active Ingredients: Light Mineral Oil (1.0%) (Emollient), Mineral Oil (4.5%) (Emollient)Inactive Ingredients: Edetate Disodium, Octoxynol 40, Polyhexamethylene Biguanide (preservative), Polysorbate 80, Water Purified, Sodium Chloride, Sodium Hydroxide (and/or), Hydrochloric Acid (to adjust pH), Sodium Phosphate Dibasic, Sodium Phosphate Monobasic

Directions from packaging: Remove contact lenses before use. Shake well before using. Instill 1 or 2 drop(s) in the affected eye(s) as needed or as directed by your doctor. Other Information: temporarily blurred vision is typical upon application. Drops appear as a milky white solution. Store at 15°-30°C (59°-86°F).

Warnings from packaging: WarningsFor external use only. Do not use if solution changes color. When using this product, do not touch the tip of container to any surface. Replace cap after using. Stop and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if condition worsens or persists for more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Tamper Evident: Do not use if imprinted "Protective Seal" with Yellow is not intact.

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ingredients

	score	data gap	concerns
OCTOXYNOL-40	9	68%	Violations, restrictions & warnings, Endocrine disruption, Allergies/immunotoxicity, Organ system toxicity (non-reproductive), Multiple, additive exposure sources, Irritation (skin, eyes, or lungs), Contamination concerns (ETHYLENE OXIDE, 1,4-DIOXANE, C9 PHENOLS, ETHYLENE OXIDE, 1,4-DIOXANE, C9 PHENOLS)
MINERAL OIL	2	73%	Organ system toxicity (non-reproductive), Occupational hazards
DISODIUM EDTA EDETATE DISODIUM	3	78%	Neurotoxicity, Organ system toxicity (non-reproductive), Enhanced skin absorption
SODIUM HYDROXIDE	3	77%	Neurotoxicity, Organ system toxicity (non-reproductive), Irritation (skin, eyes, or lungs)
HYDROCHLORIC ACID	2	65%	Organ system toxicity (non-reproductive), Irritation (skin, eyes, or lungs), Occupational hazards
POLYSORBATE-80	2	80%	Developmental/reproductive toxicity
SODIUM PHOSPHATE	1	89%	none identified
DISODIUM PHOSPHATE SODIUM PHOSPHATE DIBASIC	1	86%	none identified
POLYHEXAMETHYLENE BIGUANIDE	0	100%	none identified
SODIUM CHLORIDE	0	0%	innocuous
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		MINERAL OIL
One or more in vitro tests on mammalian cells show positive mutation results		OCTOXYNOL-40, SODIUM HYDROXIDE, SODIUM CHLORIDE, POLYSORBATE-80, DISODIUM EDTA
Cancer - not classifiable/not likely to be human carcinogen		HYDROCHLORIC ACID

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		OCTOXYNOL-40, DISODIUM EDTA
One or more animal studies show reproductive effects at very low doses		POLYSORBATE-80

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 - Restrictions on impurities recommended by industry safety panel		OCTOXYNOL-40, OCTOXYNOL-40
Recommended restricted in cosmetics - use, concentration, or manufacturing restrictions - Product type restrictions or differences noted in safety assessment by industry panel		OCTOXYNOL-40

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 moderate doses		DISODIUM PHOSPHATE
One or more animal studies show brain and nervous system effects at high doses		POLYSORBATE-80
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 very low doses		SODIUM HYDROXIDE

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
Limited evidence of endocrine disruption		OCTOXYNOL-40

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)
Human skin toxicant - strong evidence		OCTOXYNOL-40

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 sense organ effects at moderate doses (low dose studies may be unavailable for this ingredient)	products for use around the eyes, mouth, or lips	POLYSORBATE-80
One or more animal studies show broad systemic effects at moderate doses (low dose studies may be unavailable for this ingredient)		SODIUM PHOSPHATE, DISODIUM PHOSPHATE
One or more animal studies show sense organ effects at low doses	products for use around the eyes, mouth, or lips	SODIUM CHLORIDE
Limited evidence of sense organ toxicity		HYDROCHLORIC ACID
One or more animal studies show sense organ effects at low doses	products for use around the eyes, mouth, or lips	MINERAL OIL
One or more animal studies show broad systemic effects at low doses		OCTOXYNOL-40, DISODIUM EDTA
One or more animal studies show metabolic effects at very low doses		SODIUM HYDROXIDE

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 PHOSPHATE, SODIUM HYDROXIDE, SODIUM CHLORIDE, POLYSORBATE-80, MINERAL OIL, HYDROCHLORIC ACID, DISODIUM PHOSPHATE, DISODIUM EDTA
Used in food or as an additive with limited or no toxicity information available		OCTOXYNOL-40

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		OCTOXYNOL-40
Not suspected to be an environmental toxin		SODIUM HYDROXIDE, HYDROCHLORIC ACID

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		SODIUM CHLORIDE, MINERAL OIL, HYDROCHLORIC ACID, DISODIUM PHOSPHATE
One or more animal studies show skin irritation at very low doses		SODIUM HYDROXIDE
Human any irritant - strong evidence	products for use around the eyes, on the skin, or may be aerosolized (airborne)	OCTOXYNOL-40

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		OCTOXYNOL-40
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		OCTOXYNOL-40, DISODIUM EDTA, POLYSORBATE-80
Not assessed for safety in cosmetics by industry panel		SODIUM PHOSPHATE, SODIUM HYDROXIDE, POLYHEXAMETHYLENE BIGUANIDE, MINERAL OIL, HYDROCHLORIC ACID, DISODIUM PHOSPHATE

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)
No workplace limits set		SODIUM HYDROXIDE
Allowed workplace exposures restricted to very low doses		HYDROCHLORIC ACID
Allowed workplace exposures restricted to moderate doses		MINERAL OIL