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

Description

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

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

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

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]

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

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.

Purpose

Sunscreen

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

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]

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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