CHEM FREE SUNSCREEN TINTED FORMULA- zinc oxide cream

Chem Free Sunscreen Tinted Formula by

Drug Labeling and Warnings

Chem Free Sunscreen Tinted Formula by is a Otc medication manufactured, distributed, or labeled by IT INTELLIGENT TREATMENT 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

CHEM FREE SUNSCREEN TINTED FORMULA 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85507-204
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
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
CI 77499 (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CI 77491 (UNII: 1K09F3G675)
CI 77492 (UNII: EX438O2MRT)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCERIN (UNII: PDC6A3C0OX)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85507-204-60	60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/12/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/12/2024

Labeler - IT INTELLIGENT TREATMENT LLC (104100943)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing INC		793406000	manufacture(85507-204)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85507-204)