clarins - broad spectrum spf 50+ sunscreen body lotion spray

clarins - broad spectrum spf 50+ sunscreen body lotion spray
SPL v1
SPL
SPL Set ID 7feb0679-6557-4917-a386-7ce2c14a94e2
Route
topical
Published
Effective Date 2023-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (100 mg) octinoxate (75 mg) octisalate (50 mg) octocrylene
Inactive Ingredients
water butyloctyl salicylate styrene butylene glycol polyglyceryl-6 stearate polyester-7 neopentyl glycol diheptanoate aloe vera leaf diethylhexyl syringylidenemalonate polysilicone-15 mannitol potassium cetyl phosphate phenoxyethanol peg-8 laurate dimethicone glycerin polyglyceryl-6 behenate edetate disodium anhydrous ethylhexylglycerin .alpha.-tocopherol acetate ammonium acryloyldimethyltaurate, dimethylacrylamide, lauryl methacrylate and laureth-4 methacrylate copolymer, trimethylolpropane triacrylate crosslinked (45000 mpa.s) sodium dehydroacetate medium-chain triglycerides tocopherol cyclodextrins pea senna alata leaf yeast, unspecified butylated hydroxytoluene olea europaea leaf tert-butyl alcohol platanus occidentalis bark citric acid monohydrate potassium sorbate sodium benzoate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-01-01

Purpose

Sunscreen

Description

AVOBENZONE 3%, HOMOSALATE 10%, OCTINOXATE 7.5%, OCTISALATE 5%, OCTOCRYLENE 10%


Medication Information

Purpose

Sunscreen

Inactive Ingredients

AQUA/WATER/EAU . BUTYLOCTYL SALICYLATE . STYRENE/ACRYLATES COPOLYMER . BUTYLENE GLYCOL . POLYGLYCERYL-6 STEARATE . POLYESTER-7 . NEOPENTYL GLYCOL DIHEPTANOATE . ALOE BARBADENSIS LEAF JUICE . DIETHYLHEXYL SYRINGYLIDENEMALONATE . PARFUM/FRAGRANCE . POLYSILICONE-15 . MANNITOL . POTASSIUM CETYL PHOSPHATE . PHENOXYETHANOL . PEG-8 LAURATE . DIMETHICONE . GLYCERIN . POLYGLYCERYL- 6 BEHENATE . DISODIUM EDTA . ETHYLHEXYLGLYCERIN . TOCOPHERYL ACETATE . POLYACRYLATE CROSSPOLYMER-6 . SODIUM DEHYDROACETATE . CAPRYLIC/CAPRIC TRIGLYCERIDE . TOCOPHEROL . DIMETHICONOL . CYCLODEXTRIN . PISUM SATIVUM (PEA) EXTRACT . CASSIA ALATA LEAF EXTRACT . FAEX EXTRACT/YEAST EXTRACT/EXTRAIT DE LEVURE . DEXTRIN . HYDROLYZED ADANSONIA DIGITATA EXTRACT . BHT . OLEA EUROPAEA (OLIVE) LEAF EXTRACT . T-BUTYL ALCOHOL . PLATANUS OCCIDENTALIS BARK EXTRACT . CITRIC ACID . POTASSIUM SORBATE . SODIUM BENZOATE. [S2031C]

Description

AVOBENZONE 3%, HOMOSALATE 10%, OCTINOXATE 7.5%, OCTISALATE 5%, OCTOCRYLENE 10%

Uses:

• helps prevent sunburn • if used as directed with other sun protection measures (see

Directions)

, decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings:

For external use only.

Do Not Use

• on damaged or broken skin.

Directions:

• apply liberally 15 minutes before sun exposure • apply to all skin exposed to the sun • children under 6 months: Ask a doctor

• Sun Protection Measures.

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats and sunglasses • reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating

Package Labeling:

Active Ingredients

AVOBENZONE 3%,

HOMOSALATE 10%,

OCTINOXATE 7.5%,

OCTISALATE 5%,

OCTOCRYLENE 10%

Other Information:

• protect this product from excessive heat and direct sun

Questions Or Comments?

Call 1-866-325-2746 Monday-Friday 9am to 6:30pm ET

When Using This Product

• keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If

• rash occurs.

Keep Out of Reach of Children.

If product is swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Purpose

Sunscreen

Inactive Ingredients (Inactive ingredients)

AQUA/WATER/EAU . BUTYLOCTYL SALICYLATE . STYRENE/ACRYLATES COPOLYMER . BUTYLENE GLYCOL . POLYGLYCERYL-6 STEARATE . POLYESTER-7 . NEOPENTYL GLYCOL DIHEPTANOATE . ALOE BARBADENSIS LEAF JUICE . DIETHYLHEXYL SYRINGYLIDENEMALONATE . PARFUM/FRAGRANCE . POLYSILICONE-15 . MANNITOL . POTASSIUM CETYL PHOSPHATE . PHENOXYETHANOL . PEG-8 LAURATE . DIMETHICONE . GLYCERIN . POLYGLYCERYL- 6 BEHENATE . DISODIUM EDTA . ETHYLHEXYLGLYCERIN . TOCOPHERYL ACETATE . POLYACRYLATE CROSSPOLYMER-6 . SODIUM DEHYDROACETATE . CAPRYLIC/CAPRIC TRIGLYCERIDE . TOCOPHEROL . DIMETHICONOL . CYCLODEXTRIN . PISUM SATIVUM (PEA) EXTRACT . CASSIA ALATA LEAF EXTRACT . FAEX EXTRACT/YEAST EXTRACT/EXTRAIT DE LEVURE . DEXTRIN . HYDROLYZED ADANSONIA DIGITATA EXTRACT . BHT . OLEA EUROPAEA (OLIVE) LEAF EXTRACT . T-BUTYL ALCOHOL . PLATANUS OCCIDENTALIS BARK EXTRACT . CITRIC ACID . POTASSIUM SORBATE . SODIUM BENZOATE. [S2031C]

Uses:

• helps prevent sunburn • if used as directed with other sun protection measures (see

Directions)

, decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings:

For external use only.

Do Not Use (Do not use)

• on damaged or broken skin.

Directions:

• apply liberally 15 minutes before sun exposure • apply to all skin exposed to the sun • children under 6 months: Ask a doctor

• Sun Protection Measures.

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats and sunglasses • reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating

Package Labeling:

Active Ingredients (Active ingredients)

AVOBENZONE 3%,

HOMOSALATE 10%,

OCTINOXATE 7.5%,

OCTISALATE 5%,

OCTOCRYLENE 10%

Other Information: (Other information:)

• protect this product from excessive heat and direct sun

Questions Or Comments? (Questions or comments?)

Call 1-866-325-2746 Monday-Friday 9am to 6:30pm ET

When Using This Product (When using this product)

• keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• rash occurs.

Keep Out of Reach of Children. (Keep out of reach of children.)

If product is swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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