MOISTURIZING FACE AND BODY SPF- zinc oxide cream

Moisturizing Face and Body SPF by

Drug Labeling and Warnings

Moisturizing Face and Body SPF by is a Otc medication manufactured, distributed, or labeled by SKIN MAVEN, 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

MOISTURIZING FACE AND BODY SPF 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85552-205(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
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85552-205-04	113 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/28/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/28/2023

Labeler - SKIN MAVEN (078866620)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85552-205)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc		793406000	manufacture(85552-205)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85552-205)