SPL v1
SPL
SPL Set ID 1e76413d-848e-21ee-e063-6394a90ac9e0
Route
TOPICAL
Published
Effective Date 2024-07-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (5 g) Homosalate (15 g) Octocrylene (10 g) Avobenzone (3 g)
Inactive Ingredients
Senna Alata Leaf Acrylic Acid/2-ethylhexyl Acrylate/styrene Copolymer (500000 Mw) Peg-8 Laurate Sodium Dodecylbenzenesulfonate P-anisic Acid Water Polyoxyl 100 Stearate Type I Panthenol Tocopherol Trolamine Maltodextrin Silicon Dioxide Caprylyl Trisiloxane Glyceryl Monostearate Diethylhexyl Syringylidenemalonate Dimethicone Polymethylsilsesquioxane (4.5 Microns) Caprylyl Glycol Chlorphenesin Behenyl Acrylate Polymer Edetate Disodium Anhydrous Xanthan Gum Medium-chain Triglycerides Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s At 0.5%) Potassium Cetyl Phosphate 2-ethylhexyl Acrylate, Methacrylate, Methyl Methacrylate, Or Butyl Methacrylate/hydroxypropyl Dimethicone Copolymer (30000-300000 Mw) Glycerin Inulin Lauryl Carbamate Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-30

Description

Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 10%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 10%

Use

● 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

Section 51945-4

Stop Use

If discomfort persists.

Warnings

Forexternal use only

Do Not Use

■On irritated skin and any area that is infected or reddened.

■If pregnant or if there is any allergic reaction to this product.

When Using

avoid contact witheyes

Active Ingredient

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Inactive Ingredients

GLYCERYL MONOSTEARATE,2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW),DIETHYLHEXYL SYRINGYLIDENEMALONATE,CAPRYLYL GLYCOL,CHLORPHENESIN,EDETATE DISODIUM ANHYDROUS,BEHENYL ACRYLATE POLYMER,POLYOXYL 100 STEARATE,TOCOPHEROL,TROLAMINE,SENNA ALATA LEAF,GLYCERIN,DIMETHICONE,ACRYLIC ACID/2-ETHYLHEXYL ACRYLATE/STYRENE COPOLYMER (500000 MW) ,ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S),XANTHAN GUM,WATER,POTASSIUM CETYL PHOSPHATE ,PANTHENOL ,PEG-8 LAURATE,INULIN LAURYL CARBAMATE,P-ANISIC ACID,MEDIUM-CHAIN TRIGLYCERIDES,MALTODEXTRIN,SODIUM DODECYLBENZENESULFONATE,POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) ,SILICON DIOXIDE,CAPRYLYL TRISILOXANE,PHENOXYETHANOL

Keep Out of Reach of Children

■If product gets into eyes, flush with water for 15 minutes

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

Dosage & Administration Section

Apply according to actual needs each time. Each 100ml contains Avobenzone 3g, Homosalate 15%, Octisalate 5%, Octocrylene 10%


Structured Label Content

Use

● 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

Section 51945-4 (51945-4)

Purpose

Sunscreen

Stop Use

If discomfort persists.

Warnings

Forexternal use only

Do Not Use (Do not use)

■On irritated skin and any area that is infected or reddened.

■If pregnant or if there is any allergic reaction to this product.

When Using

avoid contact witheyes

Active Ingredient

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Inactive Ingredients (Inactive ingredients)

GLYCERYL MONOSTEARATE,2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW),DIETHYLHEXYL SYRINGYLIDENEMALONATE,CAPRYLYL GLYCOL,CHLORPHENESIN,EDETATE DISODIUM ANHYDROUS,BEHENYL ACRYLATE POLYMER,POLYOXYL 100 STEARATE,TOCOPHEROL,TROLAMINE,SENNA ALATA LEAF,GLYCERIN,DIMETHICONE,ACRYLIC ACID/2-ETHYLHEXYL ACRYLATE/STYRENE COPOLYMER (500000 MW) ,ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S),XANTHAN GUM,WATER,POTASSIUM CETYL PHOSPHATE ,PANTHENOL ,PEG-8 LAURATE,INULIN LAURYL CARBAMATE,P-ANISIC ACID,MEDIUM-CHAIN TRIGLYCERIDES,MALTODEXTRIN,SODIUM DODECYLBENZENESULFONATE,POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) ,SILICON DIOXIDE,CAPRYLYL TRISILOXANE,PHENOXYETHANOL

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

■If product gets into eyes, flush with water for 15 minutes

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

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Apply according to actual needs each time. Each 100ml contains Avobenzone 3g, Homosalate 15%, Octisalate 5%, Octocrylene 10%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)