SOL PURPOSE MINERAL SUNSCREEN TINTED- zinc oxide cream

Sol Purpose Mineral Sunscreen Tinted by

Drug Labeling and Warnings

Sol Purpose Mineral Sunscreen Tinted by is a Otc medication manufactured, distributed, or labeled by TRU SKIN RITUALS, 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

SOL PURPOSE MINERAL SUNSCREEN TINTED 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85317-204
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
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
WATER (UNII: 059QF0KO0R)
CI 77491 (UNII: 1K09F3G675)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CI 77492 (UNII: EX438O2MRT)
MICA (UNII: V8A1AW0880)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CI 77499 (UNII: XM0M87F357)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYSORBATE 20 (UNII: 7T1F30V5YH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85317-204-60	60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/27/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/27/2023

Labeler - TRU SKIN RITUALS (013644226)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(85317-204)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85317-204)