COMFORT MINERAL MOUSSE SUNSCREEN- titanium dioxide, zinc oxide aerosol, foam
Comfort Mineral Mousse Sunscreen by
Drug Labeling and Warnings
Comfort Mineral Mousse Sunscreen by is a Otc medication manufactured, distributed, or labeled by BIOHEALTH PLUS LLC, 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
COMFORT MINERAL MOUSSE SUNSCREEN
titanium dioxide, zinc oxide aerosol, foamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 85403-211 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 WATER (UNII: 059QF0KO0R) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) GLYCERYL STEARATE (UNII: 230OU9XXE4) ISODODECANE (UNII: A8289P68Y2) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) CELLULOSE GUM (UNII: K679OBS311) CETEARYL ALCOHOL (UNII: 2DMT128M1S) CITRIC ACID (UNII: 2968PHW8QP) GLYCERETH-26 (UNII: NNE56F2N14) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) OCTYLDODECYL ERUCATE (UNII: D4N66T98C2) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) 1,3,3,3-TETRAFLUOROPROPENE, (1E)- (UNII: 5I2481UOO8) TRIACONTANYL PVP (UNII: N0SS3Q238D) GLYCERIN (UNII: PDC6A3C0OX) C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ) CAPRYLYL GLYCOL (UNII: 00YIU5438U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CETEARETH-20 (UNII: YRC528SWUY) ISOHEXADECANE (UNII: 918X1OUF1E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 85403-211-04 100 g in 1 CYLINDER; Type 0: Not a Combination Product 03/21/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 03/21/2023 Labeler - BIOHEALTH PLUS LLC (869441449) Establishment Name Address ID/FEI Business Operations Fragrance Manufacturing INC 793406000 manufacture(85403-211) Establishment Name Address ID/FEI Business Operations Custom Analytics LLC 144949372 analysis(85403-211)
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