MINERAL SUNSCREEN FOR FACE AND BODY- zinc oxide cream

Mineral Sunscreen For Face and Body by

Drug Labeling and Warnings

Mineral Sunscreen For Face and Body by is a Otc medication manufactured, distributed, or labeled by Skin Philosophy by Kelly, 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

MINERAL SUNSCREEN FOR FACE AND BODY 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85330-205
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
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
WATER (UNII: 059QF0KO0R)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
GLYCERIN (UNII: PDC6A3C0OX)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85330-205-15	1.5 g in 1 PACKET; Type 0: Not a Combination Product	05/10/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/10/2023

Labeler - Skin Philosophy by Kelly (040889756)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(85330-205)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85330-205)