Clarins – Multi-intensive Jour / Super Restorative Day Cream Broad Spectrum – Spf 15 - Sunscreen

Clarins – Multi-intensive Jour / Super Restorative Day Cream Broad Spectrum – Spf 15 - Sunscreen
SPL v3
SPL
SPL Set ID 157cb8ca-1a36-41fb-be9e-b157b146dc4d
Route
TOPICAL
Published
Effective Date 2025-05-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (80 mg) Octisalate (45 mg) Octocrylene (60 mg)
Inactive Ingredients
Water Dicaprylyl Carbonate Glycerin Butyloctyl Salicylate Pentylene Glycol Cetostearyl Alcohol Ascorbyl Glucoside Potassium Cetyl Phosphate Squalane Dimethicone Butylene Glycol Cetearyl Glucoside Sodium Hydroxide Xylitylglucoside Hydroxyacetophenone Sodium Citrate Anhydroxylitol Ethylhexylglycerin .alpha.-tocopherol Acetate Xanthan Gum Titanium Dioxide Medium-chain Triglycerides Magnesium Potassium Aluminosilicate Fluoride Xylitol Edetate Disodium Anhydrous Sodium Lactate Sucrose Palmitate Anhydrous Dextrose Carbomer Homopolymer, Unspecified Type Citric Acid Monohydrate Horehound Coco Glucoside Balanites Roxburghii Seed Oil Glyceryl Linoleate Phenylethyl Alcohol Furcelleran Stannic Oxide Tocopherol Potassium Sorbate Propanediol Pectin Hyaluronate Sodium Fd&c Red No. 4 Palmitoyl Tripeptide-1 Lapsana Communis Flowering Top Palmitoyl Tetrapeptide-7

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-01

Description

AVOBENZONE 3% HOMOSALATE 8% OCTISALATE 4.5% OCTOCRYLENE 6%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

AVOBENZONE 3% HOMOSALATE 8% OCTISALATE 4.5% OCTOCRYLENE 6%

Uses:

• helps prevent sunburn • if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun

Directions

Warnings:

For external use only.

Do Not Use

• on damaged or broken skin.

Drug Facts

Directions:

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



• Spending time in the sun in creases 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 sun screen if swimming or sweating Sun Protection Measures.







Package Labeling:

Active Ingredients

AVOBENZONE 3%

HOMOSALATE 8%

OCTISALATE 4.5%

OCTOCRYLENE 6%

Other Information:

• protect this product from excessive heat and direct sun

Inactive Ingredients:

AQUA/WATER/EAU . DICAPRYLYL CARBONATE . GLYCERIN . BUTYLOCTYL SALICYLATE . PENTYLENE GLYCOL . CETEARYL ALCOHOL . ASCORBYL GLUCOSIDE . POTASSIUM CETYL PHOSPHATE . SQUALANE . DIMETHICONE . PARFUM/FRAGRANCE . BUTYLENE GLYCOL . CETEARYL GLUCOSIDE . ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER . SODIUM HYDROXIDE . XYLITYLGLUCOSIDE . HYDROXYACETOPHENONE . SODIUM CITRATE . ANHYDROXYLITOL . ETHYLHEXYLGLYCERIN . TOCOPHERYL ACETATE . XANTHAN GUM . CI 77891/TITANIUM DIOXIDE . CAPRYLIC/CAPRIC TRIGLYCERIDE . SYNTHETIC FLUORPHLOGOPITE . DIMETHICONOL . XYLITOL . DISODIUM EDTA . SODIUM LACTATE . SUCROSE PALMITATE . GLUCOSE . CARBOMER . CITRIC ACID . HARUNGANA MADAGASCARIENSIS EXTRACT . MARRUBIUM VULGARE EXTRACT . COCO-GLUCOSIDE . BALANITES ROXBURGHII SEED OIL . GLYCERYL LINOLEATE . PHENETHYL ALCOHOL . FURCELLARIA LUMBRICALIS EXTRACT . PANCRATIUM MARITIMUM EXTRACT . TIN OXIDE . ULEX EUROPAEUS LEAF/ROOT/STEM EXTRACT . TOCOPHEROL . POTASSIUM SORBATE . PROPANEDIOL . PECTIN . SODIUM HYALURONATE . GUAR HYDROXYPROPYLTRIMO- NIUM CHLORIDE . CI 14700/RED 4 . PALMITOYL TRIPEPTIDE-1 . LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT . MARIS SAL/SEA SALT/SEL MARIN . PALMITOYL TETRAPEPTIDE-7. [S4041A]

Questions Or Comments?

Call 1-866-325-2746 Monday-Friday 9 a.m. to 6:30 p.m. 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 me dical 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 ), decreases the risk of skin cancer and early skin aging caused by the sun

Directions

Purpose

Sunscreen

Warnings:

For external use only.

Do Not Use (Do not use)

• on damaged or broken skin.

Drug Facts (Drug facts)

Directions:

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



• Spending time in the sun in creases 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 sun screen if swimming or sweating Sun Protection Measures.







Package Labeling:

Active Ingredients (Active ingredients)

AVOBENZONE 3%

HOMOSALATE 8%

OCTISALATE 4.5%

OCTOCRYLENE 6%

Other Information: (Other information:)

• protect this product from excessive heat and direct sun

Inactive Ingredients: (Inactive ingredients:)

AQUA/WATER/EAU . DICAPRYLYL CARBONATE . GLYCERIN . BUTYLOCTYL SALICYLATE . PENTYLENE GLYCOL . CETEARYL ALCOHOL . ASCORBYL GLUCOSIDE . POTASSIUM CETYL PHOSPHATE . SQUALANE . DIMETHICONE . PARFUM/FRAGRANCE . BUTYLENE GLYCOL . CETEARYL GLUCOSIDE . ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER . SODIUM HYDROXIDE . XYLITYLGLUCOSIDE . HYDROXYACETOPHENONE . SODIUM CITRATE . ANHYDROXYLITOL . ETHYLHEXYLGLYCERIN . TOCOPHERYL ACETATE . XANTHAN GUM . CI 77891/TITANIUM DIOXIDE . CAPRYLIC/CAPRIC TRIGLYCERIDE . SYNTHETIC FLUORPHLOGOPITE . DIMETHICONOL . XYLITOL . DISODIUM EDTA . SODIUM LACTATE . SUCROSE PALMITATE . GLUCOSE . CARBOMER . CITRIC ACID . HARUNGANA MADAGASCARIENSIS EXTRACT . MARRUBIUM VULGARE EXTRACT . COCO-GLUCOSIDE . BALANITES ROXBURGHII SEED OIL . GLYCERYL LINOLEATE . PHENETHYL ALCOHOL . FURCELLARIA LUMBRICALIS EXTRACT . PANCRATIUM MARITIMUM EXTRACT . TIN OXIDE . ULEX EUROPAEUS LEAF/ROOT/STEM EXTRACT . TOCOPHEROL . POTASSIUM SORBATE . PROPANEDIOL . PECTIN . SODIUM HYALURONATE . GUAR HYDROXYPROPYLTRIMO- NIUM CHLORIDE . CI 14700/RED 4 . PALMITOYL TRIPEPTIDE-1 . LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT . MARIS SAL/SEA SALT/SEL MARIN . PALMITOYL TETRAPEPTIDE-7. [S4041A]

Questions Or Comments? (Questions or comments?)

Call 1-866-325-2746 Monday-Friday 9 a.m. to 6:30 p.m. 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 me dical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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