42c74ddf-70a3-f2b1-e063-6294a90a91a9

SPL v3

SPL

SPL Set ID 42c74ddf-70a3-f2b1-e063-6294a90a91a9

Route

topical

Published

Effective Date 2025-11-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

ensulizole (1 mg) homosalate (13 mg) octisalate (2 mg) avobenzone (14 mg) octocrylene (5 mg)

Inactive Ingredients

acrylates/c10-30 alkyl acrylate crosspolymer (60000 mpa.s) cetyl alcohol decylene glycol beeswax phenoxyethanol water carbomer magnesium disodium edta sodium stearoyl lactylate sodium hydroxide glyceryl stearate citrate caprylyl glycol ethylhexyl isononanoate peg-100 hydroxyacetophenone

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2025-11-01

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

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Source: dailymed · Ingested: 2026-02-15T12:08:54.874570 · Updated: 2026-03-14T23:13:23.763125