41cca42f-3d2a-9a32-e063-6394a90a03e1

SPL v1

SPL

SPL Set ID 41cca42f-3d2a-9a32-e063-6394a90a03e1

Route

cutaneous

Published

Effective Date 2025-09-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

homosalate (4.75 g) ethylhexyl salicylate (2.5 g) titanium dioxide (1 g) butyl methoxydibenzoylmethane (1.5 g) ethylhexyl methoxycinnamate octocrylene

Inactive Ingredients

triethoxycaprylylsilane polyhydroxystearic acid (2300 mw) trimethylpentanediol/adipic acid/glycerin crosspolymer (25000 mpa.s) tocopheryl retinoate hydrated silica microcrystalline wax c12-15 alkyl benzoate beeswax butyl acrylate/c16-c20 alkyl methacrylate/methacrylic acid/methyl methacrylate copolymer

Identifiers & Packaging

Pill Appearance

Color: green

Marketing Status

otc monograph drug active Since 2025-09-01

Medication Information

Warnings and Precautions

Indications and Usage

Dosage and Administration

Section 50565-1

Section 51727-6

Section 51945-4

Section 55105-1

Structured Label Content

Warnings and Precautions (34071-1)

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

Section 50565-1 (50565-1)

Section 51727-6 (51727-6)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:46.945006 · Updated: 2026-03-14T23:13:09.195902