MINERAL BASED FOAM SUNSCREEN TINTED- titanium dioxide, zinc oxide aerosol, foam
Mineral Based Foam Sunscreen Tinted by
Drug Labeling and Warnings
Mineral Based Foam Sunscreen Tinted by is a Otc medication manufactured, distributed, or labeled by KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION, Tri Pac, Inc., Fallien Cosmeceuticals Ltd.. 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
MINERAL BASED FOAM SUNSCREEN TINTED
titanium dioxide, zinc oxide aerosol, foamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 81679-210(NDC:58892-210) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 30 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 100 mg in 1 g Inactive Ingredients Ingredient Name Strength BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CI 77492 (UNII: EX438O2MRT) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ) CI 77491 (UNII: 1K09F3G675) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) CETEARETH-20 (UNII: YRC528SWUY) CETEARYL ALCOHOL (UNII: 2DMT128M1S) CITRIC ACID (UNII: 2968PHW8QP) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ISODODECANE (UNII: A8289P68Y2) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V) MICA (UNII: V8A1AW0880) OCTYLDODECYL ERUCATE (UNII: D4N66T98C2) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CELLULOSE GUM (UNII: K679OBS311) GLYCERIN (UNII: PDC6A3C0OX) 1,3,3,3-TETRAFLUOROPROPENE, (1E)- (UNII: 5I2481UOO8) CI 77499 (UNII: XM0M87F357) POLYSORBATE 80 (UNII: 6OZP39ZG8H) GLYCERETH-26 (UNII: NNE56F2N14) GLYCERYL STEARATE (UNII: 230OU9XXE4) ISOHEXADECANE (UNII: 918X1OUF1E) TRIACONTANYL PVP (UNII: N0SS3Q238D) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 81679-210-04 100 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 06/10/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 06/10/2021 Labeler - KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION (792310955) Establishment Name Address ID/FEI Business Operations Tri Pac, Inc. 020844956 manufacture(81679-210) Establishment Name Address ID/FEI Business Operations Fallien Cosmeceuticals Ltd. 958388357 relabel(81679-210)
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