TINTED MINERAL SUNSCREEN- titanium dioxide, zinc oxide cream
Tinted Mineral Sunscreen by
Drug Labeling and Warnings
Tinted Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION, Fragrance Manufacturing INC, Custom Analytics LLC. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TINTED MINERAL SUNSCREEN
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 85585-203 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 80 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 38 mg in 1 g Inactive Ingredients Ingredient Name Strength DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y) CI 77492 (UNII: EX438O2MRT) CI 77499 (UNII: XM0M87F357) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) CYCLOHEXASILOXANE (UNII: XHK3U310BA) CYCLOPENTASILOXANE (UNII: 0THT5PCI0R) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6) CI 77491 (UNII: 1K09F3G675) HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX) ALUMINA (UNII: LMI26O6933) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 85585-203-15 1.5 g in 1 PACKET; Type 0: Not a Combination Product 03/23/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 03/23/2021 Labeler - JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION (557562910) Establishment Name Address ID/FEI Business Operations Fragrance Manufacturing INC 793406000 manufacture(85585-203) Establishment Name Address ID/FEI Business Operations Custom Analytics LLC 144949372 analysis(85585-203)
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