SPL v2
SPL
SPL Set ID 380416b9-180a-3904-e063-6294a90a7bee
Route
TOPICAL
Published
Effective Date 2025-06-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (200 mg)
Inactive Ingredients
Caprylyl Glycol Peg-30 Dipolyhydroxystearate Polysorbate 20 Water Polyglyceryl-4 Isostearate Caprylhydroxamic Acid Edetate Disodium Anhydrous Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Cyclohexasiloxane Dimethicone Crosspolymer Alpha-tocopherol Acetate Triethanolamine Microcrystalline Wax Ci 77491 Ci 77492 Ci 77499 Cyclopentasiloxane Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Polyhydroxystearic Acid (2300 Mw) Dimethicone Bismuth Oxychloride Hydrogen Dimethicone (20 Cst) Peg-10 Dimethicone (600 Cst) Tetrahexyldecyl Ascorbate Glycerin Stearyl Dimethicone (400 Mpa.s At 50c) Triethoxycaprylylsilane Mica Sodium Chloride Dimethiconol (2000 Cst) C12-15 Alkyl Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-10


Medication Information

Section 51945-4


Structured Label Content

Section 51945-4 (51945-4)


Advanced Ingredient Data


Raw Label Data

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