ANTIOXIDANT MINERAL SUNSCREEN PLUS PRIMER LIGHTLY TINTED- zinc oxide cream

Antioxidant Mineral Sunscreen Plus Primer Lightly Tinted by

Drug Labeling and Warnings

Antioxidant Mineral Sunscreen Plus Primer Lightly Tinted by is a Otc medication manufactured, distributed, or labeled by True Beauty Brows & Skin Care, Custom Analytics LLC, Fragrance Manufacturing INC, Skin Science Institute 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

ANTIOXIDANT MINERAL SUNSCREEN PLUS PRIMER LIGHTLY TINTED 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85520-208(NDC:58892-208)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	160 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
CERAMIDE 3 (UNII: 4370DF050B)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
CI 77492 (UNII: EX438O2MRT)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
CI 77491 (UNII: 1K09F3G675)
CI 77499 (UNII: XM0M87F357)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85520-208-50	50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/04/2020

Labeler - True Beauty Brows & Skin Care (068063250)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85520-208)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing INC		793406000	manufacture(85520-208)

Establishment
Name	Address	ID/FEI	Business Operations
Skin Science Institute Inc		958388357	relabel(85520-208)