ACNEFIX NON-TINTED MINERAL SUNSCREEN- titanium dioxide, zinc oxide cream

AcneFix Non-Tinted Mineral Sunscreen by

Drug Labeling and Warnings

AcneFix Non-Tinted Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by ACNEFIX INC., 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

ACNEFIX NON-TINTED MINERAL SUNSCREEN 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85396-202(NDC:58892-202)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	80 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	38 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINA (UNII: LMI26O6933)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85396-202-50	53 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/16/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/16/2022

Labeler - ACNEFIX INC. (109554560)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85396-202)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(85396-202)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85396-202)