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SPL v1

SPL

SPL Set ID 2bd84b92-dcf0-404f-e063-6294a90a1060

Route

TOPICAL

Published

Effective Date 2025-01-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Octisalate (9 g) Octinoxate (63 g) Titanium Dioxide (11.2 g) Zinc Oxide

Inactive Ingredients

Malva Sylvestris Flower Cetostearyl Alcohol Isocetyl Stearate Caprylyl Glycol Phenoxyethanol Hexylene Glycol Stearic Acid Calendula Officinalis Flower Neopentyl Glycol Diheptanoate Asian Ginseng Glycerin Cetyl Alcohol Matricaria Recutita Flowering Top Sorbitol Polyoxyl 20 Cetostearyl Ether Dimethicone 350 Water Comfrey Leaf .alpha.-tocopherol Acetate Trolamine Aloe Vera Leaf Polyester-7

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-01-01

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: 2026-02-15T12:05:22.218381 · Updated: 2026-03-14T23:07:03.829205