SHIELD MINERAL SUNSCREEN NON TINTED- zinc oxide cream

Shield Mineral Sunscreen Non Tinted by

Drug Labeling and Warnings

Shield Mineral Sunscreen Non Tinted by is a Otc medication manufactured, distributed, or labeled by SMOOTHE LLC, Custom Analytics LLC, Fragrance Manufacturing INC, Fallien Cosmeceuticals Ltd.. 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

SHIELD MINERAL SUNSCREEN NON TINTED 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85417-226(NDC:58892-226)
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
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
DIMETHICONE (UNII: 92RU3N3Y1O)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CERAMIDE 3 (UNII: 4370DF050B)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85417-226-50	50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/14/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/14/2023

Labeler - SMOOTHE LLC (085215094)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85417-226)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing INC		793406000	manufacture(85417-226)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85417-226)