TINTED PHYSICAL BLOCK SUNSCREEN- titanium dioxide, zinc oxide cream

Tinted Physical Block Sunscreen by

Drug Labeling and Warnings

Tinted Physical Block Sunscreen by is a Otc medication manufactured, distributed, or labeled by Tucson Acne Clinic, Fragrance Manufacturing Inc., Custom Analytics LLC. 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

Directions:

Apply liberally 15 minutes before sun exposure

INDICATIONS & USAGE

For external use only

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

KEEP OUT OF REACH OF CHILDREN

keep out of reach of children

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TINTED PHYSICAL BLOCK SUNSCREEN 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85301-203
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
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
CI 77491 (UNII: 1K09F3G675)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINA (UNII: LMI26O6933)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85301-203-15	1.5 g in 1 PACKET; Type 0: Not a Combination Product	01/22/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/22/2024

Labeler - Tucson Acne Clinic (089299711)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(85301-203)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85301-203)