83809-020

83809-020
SPL v1
SPL
SPL Set ID 104dba3b-b740-6e26-e063-6394a90a0aa8
Route
TOPICAL
Published
Effective Date 2024-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (5 g) Homosalate (15 g) Avobenzone (3 g) Octocrylene (10 g)
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-01
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

Stop Use

rash occurs

Warnings

For external use only

Directions

For sunscreen use:

● apply generously 15 minutes before sun exposure

● reapply:

● after 80 minutes of swimming or sweating

● immediately after towel drying

● at least every 2 hours

● 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including;

● limit time in the sun, especially from 10 am.-2 p.m.

● wear long-sleeved shirts, pants, hats and sunglasses

● children under 6 months of age: Ask a doctor

Do Not Use

on damaged or broken skin

When Using

keep out of eyes. Rinse with waterto remove.

Active Ingredient

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Other Information

● protect the product in this container from excessive heat and direct sun

Inactive Ingredients

Water, polymethylsilsesquioxane, glycerin, dimethicone, poly C10-30 alkyl

acrylate, styrene/acrylates copolymer, silica, caprylyl methicone,

acrylates/dimethicone copolymer, diethylhexyl syringylidenemalonate,

PEG-100 stearate, glyceryl stearate, phenoxyethanol, potassium cetyl

phosphate, tocopherol, caprylyl glycol, panthenol, acrylates/C10-30 alkyl

acrylate crosspolymer, triethanolamine, PEG-8 laurate, inulin lauryl

carbamate, chlorphenesin, p-anisic acid, caprylic/capric triglyceride,

xanthan gum, disodium EDTA, cassia alata leaf extract, maltodextrin,

sodium dodecylbenzenesulfonate

Principal Display Panel

Keep Oot of Reach of Children

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

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

Purpose

Sunscreen

Stop Use

rash occurs

Warnings

For external use only

Directions

For sunscreen use:

● apply generously 15 minutes before sun exposure

● reapply:

● after 80 minutes of swimming or sweating

● immediately after towel drying

● at least every 2 hours

● 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including;

● limit time in the sun, especially from 10 am.-2 p.m.

● wear long-sleeved shirts, pants, hats and sunglasses

● children under 6 months of age: Ask a doctor

Do Not Use (Do not use)

on damaged or broken skin

When Using

keep out of eyes. Rinse with waterto remove.

Active Ingredient

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Other Information (Other information)

● protect the product in this container from excessive heat and direct sun

Inactive Ingredients (Inactive ingredients)

Water, polymethylsilsesquioxane, glycerin, dimethicone, poly C10-30 alkyl

acrylate, styrene/acrylates copolymer, silica, caprylyl methicone,

acrylates/dimethicone copolymer, diethylhexyl syringylidenemalonate,

PEG-100 stearate, glyceryl stearate, phenoxyethanol, potassium cetyl

phosphate, tocopherol, caprylyl glycol, panthenol, acrylates/C10-30 alkyl

acrylate crosspolymer, triethanolamine, PEG-8 laurate, inulin lauryl

carbamate, chlorphenesin, p-anisic acid, caprylic/capric triglyceride,

xanthan gum, disodium EDTA, cassia alata leaf extract, maltodextrin,

sodium dodecylbenzenesulfonate

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:45.298543 · Updated: 2026-03-14T23:02:27.804765