MINERAL STICK TINTED- titanium dioxide, zinc oxide cream

Mineral Stick Tinted by

Drug Labeling and Warnings

Mineral Stick Tinted 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

MINERAL STICK TINTED 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85507-220
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	55 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HEXYLDECANOL (UNII: 151Z7P1317)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CETYL DIMETHYLBUTYL ETHER (UNII: 7LAB1GXG9G)
CITRIC ACID (UNII: 2968PHW8QP)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
CERESIN (UNII: Q1LS2UJO3A)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ZINGIBER OFFICINALE (GINGER) ROOT OIL (UNII: SAS9Z1SVUK)
ALUMINA (UNII: LMI26O6933)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
PEG/PPG-15/15 DIMETHICONE (UNII: 184IZ28A2G)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
CI 77492 (UNII: EX438O2MRT)
PEG-8 (UNII: B697894SGQ)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
CI 77499 (UNII: XM0M87F357)
CI 77491 (UNII: 1K09F3G675)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
HEXYLDECYL LAURATE (UNII: 0V595C1P6M)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85507-220-30	30 g in 1 CYLINDER; 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(85507-220)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85507-220)