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, 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

COMFORT MINERAL MOUSSE SUNSCREEN 
titanium dioxide, zinc oxide aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85403-211(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
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)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CELLULOSE GUM (UNII: K679OBS311)
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)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
GLYCERIN (UNII: PDC6A3C0OX)
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
Custom Analytics LLC		144949372	analysis(85403-211)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing INC		793406000	manufacture(85403-211)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85403-211)