SHEER MINERAL FACE AND BODY SUNSCREEN TINTED- zinc oxide cream

Sheer Mineral Face And Body Sunscreen Tinted by

Drug Labeling and Warnings

Sheer Mineral Face And Body Sunscreen Tinted by is a Otc medication manufactured, distributed, or labeled by LAURA CATHERINE, 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

SHEER MINERAL FACE AND BODY SUNSCREEN TINTED 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85596-204(NDC:58892-204)
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
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
CI 77491 (UNII: 1K09F3G675)
CI 77499 (UNII: XM0M87F357)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
CI 77492 (UNII: EX438O2MRT)
MICA (UNII: V8A1AW0880)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
WATER (UNII: 059QF0KO0R)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85596-204-60	60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/05/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/05/2022

Labeler - LAURA CATHERINE, LLC (043384686)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85596-204)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing INC		793406000	manufacture(85596-204)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85596-204)