1e76413d-848e-21ee-e063-6394a90ac9e0

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

Purpose

Sunscreen

Description

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


Medication Information

Warnings

Forexternal use only

Purpose

Sunscreen

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

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.

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%

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

Warnings

Forexternal use only

Purpose

Sunscreen

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

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)

Stop Use

If discomfort persists.

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%

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)