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.. 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

INGREDIENTS AND APPEARANCE

MINERAL BASED FOAM SUNSCREEN TINTED 
titanium dioxide, zinc oxide aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81679-210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	100 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	30 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)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
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)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
GLYCERETH-26 (UNII: NNE56F2N14)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
ISOHEXADECANE (UNII: 918X1OUF1E)
TRIACONTANYL PVP (UNII: N0SS3Q238D)
CETEARETH-20 (UNII: YRC528SWUY)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
CITRIC ACID (UNII: 2968PHW8QP)
ISODODECANE (UNII: A8289P68Y2)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)

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)