TINTED MINERAL SUNSCREEN- titanium dioxide, zinc oxide cream

Tinted Mineral Sunscreen by

Drug Labeling and Warnings

Tinted Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Face 5, LLC, Custom Analytics LLC, Fragrance Manufacturing Inc., Fallien Cosmeceuticals Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Titanium Dioxide 8% Zinc Oxide 3.8%

Purpose:

Sunscreen

Warning:

• For external use only
• Keep out of reach of children

Warnings:

• For external use only
• Keep out of reach of children

Directions:

Apply liberally 15 minute before sun exposure

INACTIVE INGREDIENT

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI 77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

OTHER SAFETY INFORMATION

SAMPLE NOT FOR RESALE

Warning:

Keep out of reach of children

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TINTED MINERAL SUNSCREEN 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85302-203(NDC:58892-203)
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
ALUMINA (UNII: LMI26O6933)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
CI 77491 (UNII: 1K09F3G675)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85302-203-15	1.5 g in 1 PACKET; Type 0: Not a Combination Product	11/23/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/23/2022

Labeler - Face 5, LLC (119613448)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85302-203)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(85302-203)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85302-203)