TINTED PRIMER MINERAL SUNSCREEN- titanium dioxide, zinc oxide cream

Tinted Primer Mineral Sunscreen by

Drug Labeling and Warnings

Tinted Primer Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by CECILIA EDWARDS, Custom Analytics LLC, Fragrance Manufacturing 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

TINTED PRIMER MINERAL SUNSCREEN 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85640-203
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
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CI 77491 (UNII: 1K09F3G675)
ALUMINA (UNII: LMI26O6933)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
CI 77492 (UNII: EX438O2MRT)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CI 77499 (UNII: XM0M87F357)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85640-203-50	53 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/12/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/12/2022

Labeler - CECILIA EDWARDS (116365389)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85640-203)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing INC		793406000	manufacture(85640-203)