LIGHTLY TINTED MINERAL BLOCK SUNSCREEN- zinc oxide cream

Lightly Tinted Mineral Block Sunscreen by

Drug Labeling and Warnings

Lightly Tinted Mineral 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:

Zinc Oxide 16%

Purpose:

Sunscreen

Warning:

For external use only

Warning:

For external use only

Keep out of reach of children

Directions:

Apply liberally 15 minutes before sun exposure

INACTIVE INGREDIENT

Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide, Hydrogen Dimethicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer

OTHER SAFETY INFORMATION

SAMPLE NOT FOR RESALE

Warning:

Keep out of reach of children

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIGHTLY TINTED MINERAL BLOCK SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85301-208
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
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CI 77499 (UNII: XM0M87F357)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
CI 77492 (UNII: EX438O2MRT)
CI 77491 (UNII: 1K09F3G675)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CERAMIDE 3 (UNII: 4370DF050B)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85301-208-15	1.5 g in 1 PACKET; Type 0: Not a Combination Product	09/13/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/13/2022

Labeler - Tucson Acne Clinic (089299711)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(85301-208)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85301-208)