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 Maloney Plastic Surgery Skin Care, PLLC, 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: 85318-201 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 38 mg in 1 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 80 mg in 1 g Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6) ALUMINA (UNII: LMI26O6933) CI 77491 (UNII: 1K09F3G675) CI 77499 (UNII: XM0M87F357) HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CYCLOHEXASILOXANE (UNII: XHK3U310BA) CYCLOPENTASILOXANE (UNII: 0THT5PCI0R) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y) CI 77492 (UNII: EX438O2MRT) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 85318-201-85 85 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/03/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 08/03/2022 Labeler - Maloney Plastic Surgery Skin Care, PLLC (080719997) Establishment Name Address ID/FEI Business Operations Fragrance Manufacturing Inc. 793406000 manufacture(85318-201) Establishment Name Address ID/FEI Business Operations Custom Analytics LLC 144949372 analysis(85318-201)
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