SHEER MINERAL SUNSCREEN SATIN DEWY FINISH- zinc oxide cream

Sheer Mineral Sunscreen Satin Dewy Finish by

Drug Labeling and Warnings

Sheer Mineral Sunscreen Satin Dewy Finish by is a Otc medication manufactured, distributed, or labeled by TRU SKIN RITUALS, Fragrance Manufacturing Inc., Custom Analytics LLC. 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

SHEER MINERAL SUNSCREEN SATIN DEWY FINISH 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85317-205
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85317-205-15	1.5 g in 1 PACKET; Type 0: Not a Combination Product	10/27/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/27/2023

Labeler - TRU SKIN RITUALS (013644226)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(85317-205)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85317-205)