NON-TINTED MINERAL FOAMING SUNSCREEN- titanium dioxide, zinc oxide aerosol, foam

Non-Tinted Mineral Foaming Sunscreen by

Drug Labeling and Warnings

Non-Tinted Mineral Foaming Sunscreen by is a Otc medication manufactured, distributed, or labeled by Restore Skin Therapy, LLC, Custom Analytics LLC, Fragrance Manufacturing 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

INGREDIENTS AND APPEARANCE

NON-TINTED MINERAL FOAMING SUNSCREEN 
titanium dioxide, zinc oxide aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85313-211(NDC:58892-211)
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)
GLYCERETH-26 (UNII: NNE56F2N14)
OCTYLDODECYL ERUCATE (UNII: D4N66T98C2)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
TRIACONTANYL PVP (UNII: N0SS3Q238D)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
1,3,3,3-TETRAFLUOROPROPENE, (1E)- (UNII: 5I2481UOO8)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CELLULOSE GUM (UNII: K679OBS311)
ISODODECANE (UNII: A8289P68Y2)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CETEARETH-20 (UNII: YRC528SWUY)
CITRIC ACID (UNII: 2968PHW8QP)
ISOHEXADECANE (UNII: 918X1OUF1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85313-211-04	113 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/05/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/05/2019

Labeler - Restore Skin Therapy, LLC (071289893)

Registrant - Restore Skin Therapy, LLC (071289893)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85313-211)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc		793406000	manufacture(85313-211)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85313-211)