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SPL v2

SPL

SPL Set ID 3649f634-8bcd-b3c1-e063-6394a90a49d9

Route

TOPICAL

Published

Effective Date 2021-09-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

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

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-09-21

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: 2026-02-15T12:07:45.152012 · Updated: 2026-03-14T23:11:30.674942