SPL v4
SPL
SPL Set ID cc72c8c5-f3e9-e8e0-e053-2a95a90ae0b0
Route
TOPICAL
Published
Effective Date 2022-04-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (100 mg) Oxybenzone (60 mg) Avobenzone (30 mg)
Inactive Ingredients
Water Dehydrated Alcohol Alkyl (c12-15) Benzoate Glycerin Hyaluronate Sodium Onion Ceramide Ng Hydrogenated Soybean Lecithin Shea Butter Medium-chain Triglycerides Pentylene Glycol Phenoxyethanol Ammonium Acryloyldimethyltaurate/vp Copolymer Dicaprylyl Carbonate Squalane Xanthan Gum Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-29
Description

Avobenzone 3% Octocrylene 10% Oxybenzone 6%

Medication Information

Warnings and Precautions

For External use only

Indications and Usage

Helps prevent sunburn

Dosage and Administration

For Sunscreen use: Apply liberally 15 minutes before exposure

Reapply at least 2 hours

Children under 6 months : Ask a doctor

Use a water - resistant sunscreen if swimming or sweating

Description

Avobenzone 3% Octocrylene 10% Oxybenzone 6%

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50566-9

Stop use and ask a doctor:

If rash occurs

Section 50567-7

Keep out of eyes

Rinse with water to remove

Section 50570-1

Do not use on: Damaged or broken skin

Section 51727-6

Allium Cepa (Onion) Bulb Extract, Ammonium Acryloyl- Dimethyltaurate/VP Copolymer, C12-15 Alkyl Benzoate, Capryl/Capric Triglyceride, Ceramide NG, Dicaprylyl Carbonate, Disodium EDTA, Fragrance, Glycerin, Hyrogenated Lechithin, Pentylene Glycol, Phenoxyethanol, SD Alcohol 40 B, Shea Butter, Sodium Hyaluronate, Squalane, Water, Xanthan Gum

Section 51945-4

Section 53413-1

1-800-925-4733

Section 55105-1

Sunscreen

Section 55106-9

Avobenzone 3%

Octocrylene 10%

Oxybenzone 6%

Section 60561-8

Store at room temperature

Protect this product from excessive heat and direct sun

Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn

Dosage and Administration (34068-7)

For Sunscreen use: Apply liberally 15 minutes before exposure

Reapply at least 2 hours

Children under 6 months : Ask a doctor

Use a water - resistant sunscreen if swimming or sweating

Warnings and Precautions (34071-1)

For External use only

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50566-9 (50566-9)

Stop use and ask a doctor:

If rash occurs

Section 50567-7 (50567-7)

Keep out of eyes

Rinse with water to remove

Section 50570-1 (50570-1)

Do not use on: Damaged or broken skin

Section 51727-6 (51727-6)

Allium Cepa (Onion) Bulb Extract, Ammonium Acryloyl- Dimethyltaurate/VP Copolymer, C12-15 Alkyl Benzoate, Capryl/Capric Triglyceride, Ceramide NG, Dicaprylyl Carbonate, Disodium EDTA, Fragrance, Glycerin, Hyrogenated Lechithin, Pentylene Glycol, Phenoxyethanol, SD Alcohol 40 B, Shea Butter, Sodium Hyaluronate, Squalane, Water, Xanthan Gum

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-800-925-4733

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Avobenzone 3%

Octocrylene 10%

Oxybenzone 6%

Section 60561-8 (60561-8)

Store at room temperature

Protect this product from excessive heat and direct sun

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:45.881330 · Updated: 2026-03-14T23:05:42.419463