PROTECT ME NON TINTED MINERAL SPF 40- zinc oxide cream

Protect ME Non Tinted Mineral SPF 40 by

Drug Labeling and Warnings

Protect ME Non Tinted Mineral SPF 40 by is a Otc medication manufactured, distributed, or labeled by PUREFECTION LA, INC., 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

PROTECT ME NON TINTED MINERAL SPF 40 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85470-205(NDC:58892-205)
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
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
WATER (UNII: 059QF0KO0R)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85470-205-04	113 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/15/2022

Labeler - PUREFECTION LA, INC. (130869789)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85470-205)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(85470-205)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85470-205)