228b64a6-ba13-eb52-e063-6394a90a5320

SPL v1

SPL

SPL Set ID 228b64a6-ba13-eb52-e063-6394a90a5320

Route

topical

Published

Effective Date 2024-09-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

zinc oxide (5 g) titanium dioxide (6 g) octocrylene (4 g)

Inactive Ingredients

green tea leaf polyglyceryl-4 isostearate hyaluronate sodium phenoxyethanol 1,2-hexanediol water panthenol tocopherol levomenol ethylhexylglycerin butylene glycol ceramide 3 ascorbic acid ceramide 6 ii, l- silica dimethyl silylate ceramide 1 glycerin hydroxyacetophenone centella asiatica triterpenoids reynoutria japonica root

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2024-09-18

Medication Information

Warnings and Precautions

Active Ingredient

Indications and Usage

Dosage and Administration

Section 50565-1

Section 50566-9

Section 50567-7

Section 50569-3

Section 50570-1

Section 51727-6

Section 51945-4

Section 55105-1

Section 59845-8

Section 60561-8

Structured Label Content

Warnings and Precautions (34071-1)

Active Ingredient (55106-9)

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

Section 50565-1 (50565-1)

Section 50566-9 (50566-9)

Section 50567-7 (50567-7)

Section 50569-3 (50569-3)

Section 50570-1 (50570-1)

Section 51727-6 (51727-6)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Section 59845-8 (59845-8)

Section 60561-8 (60561-8)

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: 2026-02-15T12:03:36.512466 · Updated: 2026-03-14T23:03:46.018464