2096ffe7-27eb-244f-e054-00144ff8d46c

SPL v1
SPL
SPL Set ID 2096ffe7-27eb-244f-e054-00144ff8d46c
Route
topical
Published
Effective Date 2015-09-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octinoxate (0.075 g)
Inactive Ingredients
.alpha.-tocopherol acetate

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2015-09-25
Description

Octinoxate 7.5%

Medication Information

Warnings and Precautions

Keep out of reach of children

Active Ingredient

Octinoxate 7.5%

Indications and Usage

Helps protect against sunburn and chapped lips

Dosage and Administration

Topical gel

Description

Octinoxate 7.5%

Section 50565-1

Warnings: Keep out of reach of children

Section 51727-6

Hydrogenated Soybean Oil, Butyrospermum Parkii (Shea) Butter, Beeswax (CERA ALBA), Limnanthes Alba (Meadowfoam) Seed Oil, C10-18 Triglycerides, Hydrogenated Soy Polyglycerides, Flavor (Aroma), Propylene Glycol Myristyl Ether Acetate, Lauryl Lactate, Mentha Piperita (Peppermint) Oil, Salicylic Acid, Tocopheryl Acetate, C15-23 Alkane,

Sclerocarya Birrea Seed Oil, Triticum Vulgare (Wheat) Germ Oil, Cinnamal, Sucralose, Myristyl Alcohol, Propylene Glycol, Acetic Acid.

Section 53413-1

Questions or Comments? 702-347-1229 or email [email protected]

Section 55105-1

Help protect again sunburn and chapped lips

Section 59845-8

Apply liberaly 15 minutes before sun exposure

Surfbay Display Panel Jpg

Structured Label Content

Warnings and Precautions (34071-1)

Keep out of reach of children

Active Ingredient (55106-9)

Octinoxate 7.5%

Indications and Usage (34067-9)

Helps protect against sunburn and chapped lips

Dosage and Administration (34068-7)

Topical gel

Section 50565-1 (50565-1)

Warnings: Keep out of reach of children

Section 51727-6 (51727-6)

Hydrogenated Soybean Oil, Butyrospermum Parkii (Shea) Butter, Beeswax (CERA ALBA), Limnanthes Alba (Meadowfoam) Seed Oil, C10-18 Triglycerides, Hydrogenated Soy Polyglycerides, Flavor (Aroma), Propylene Glycol Myristyl Ether Acetate, Lauryl Lactate, Mentha Piperita (Peppermint) Oil, Salicylic Acid, Tocopheryl Acetate, C15-23 Alkane,

Sclerocarya Birrea Seed Oil, Triticum Vulgare (Wheat) Germ Oil, Cinnamal, Sucralose, Myristyl Alcohol, Propylene Glycol, Acetic Acid.

Section 53413-1 (53413-1)

Questions or Comments? 702-347-1229 or email [email protected]

Section 55105-1 (55105-1)

Help protect again sunburn and chapped lips

Section 59845-8 (59845-8)

Apply liberaly 15 minutes before sun exposure

Surfbay Display Panel Jpg (Surfbay Display panel jpg)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:01.082730 · Updated: 2026-03-14T22:54:10.216869