SIMPLY PROTECTED TINTED MINERAL SUNSCREEN- zinc oxide cream

Simply Protected Tinted Mineral Sunscreen by

Drug Labeling and Warnings

Simply Protected Tinted Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Healthy Skin & Body LLC, 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

SIMPLY PROTECTED TINTED MINERAL SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85726-204
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)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
CI 77491 (UNII: 1K09F3G675)
CI 77492 (UNII: EX438O2MRT)
CI 77499 (UNII: XM0M87F357)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
DIMETHICONE (UNII: 92RU3N3Y1O)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
GLYCERIN (UNII: PDC6A3C0OX)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MICA (UNII: V8A1AW0880)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85726-204-60	60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/10/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/10/2025

Labeler - Healthy Skin & Body LLC (085993044)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing INC		793406000	manufacture(85726-204)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85726-204)