Home SPL Set DailyMed SPL v1 SPL SPL Set ID 00243a6d-a409-3e63-e063-6294a90a5459 Route TOPICAL Published Effective Date 2022-08-08 Document Type 34390-5 HUMAN OTC DRUG LABEL Drug Facts Composition & Product Active Ingredients Titanium Dioxide (2.48 g) Inactive Ingredients Levomenol Phenoxyethanol Polysorbate 60 Hydrogenated Soybean Lecithin Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Xanthan Gum Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Pentylene Glycol Benzyl Alcohol Stearic Acid Aluminum Hydroxide Isohexadecane Thioctic Acid Phospholipase D1 Diethylhexyl Syringylidenemalonate Potassium Sorbate Medium-chain Triglycerides Haematococcus Pluvialis Tocopherol Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Tetrahexyldecyl Ascorbate Sorbitan Isostearate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Water Glycerin Ethylhexyl Methoxycrylene Identifiers & Packaging Pill Appearance Color: white Marketing Status OTC MONOGRAPH FINAL Active Since 2022-07-28 Medication Information Warnings and Precautions Indications and Usage Dosage and Administration Section 50565-1 Section 51727-6 Section 51945-4 Section 54433-8 Section 55105-1 Section 55106-9 Structured Label Content Indications and Usage (34067-9) Dosage and Administration (34068-7) Warnings and Precautions (34071-1) Section 50565-1 (50565-1) Section 51727-6 (51727-6) Section 51945-4 (51945-4) Section 54433-8 (54433-8) Section 55105-1 (55105-1) Section 55106-9 (55106-9) Advanced Ingredient Data [{"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "2.48", "strengthDenominator": "59", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "LEVOMENOL", "unii": "24WE03BX2T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": 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"strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}] Raw Label Data All Sections (JSON) {} Additional Information Back to search View SPL set listing Open on DailyMed ↗ Source: dailymed · Ingested: 2026-02-15T12:00:58.469112 · Updated: 2026-03-14T23:01:14.422395