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SPL v2

SPL

SPL Set ID 3766b0d8-20e6-a227-e063-6294a90af4da

Route

TOPICAL

Published

Effective Date 2019-05-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (38 mg) Titanium Dioxide (80 mg)

Inactive Ingredients

Ci 77492 Hydrogen Dimethicone (20 Cst) Dimethicone Ci 77491 Cyclopentasiloxane Tetrahexyldecyl Ascorbate Dimethiconol (2000 Cst) Alumina Dimethicone Crosspolymer Alpha-tocopherol Acetate Lauryl Peg/ppg-18/18 Methicone Cyclohexasiloxane Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Ci 77499 Peg-10 Dimethicone (600 Cst)

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-05-30

Medication Information

Section 51945-4

Structured Label Content

Section 51945-4 (51945-4)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:42.500890 · Updated: 2026-03-14T23:11:27.729526