MINERAL LIP SUNSCREEN- titanium dioxide, zinc oxide stick

Mineral Lip Sunscreen by

Drug Labeling and Warnings

Mineral Lip Sunscreen by is a Otc medication manufactured, distributed, or labeled by The Maui Medical Group, Inc, 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 LIP SUNSCREEN 
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85394-212
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	38 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CITRIC ACID (UNII: 2968PHW8QP)
DIPROPYLENE GLYCOL CAPRATE/CAPRYLATE DIESTER (UNII: R6G12EY23X)
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX (UNII: 42DG15CHXV)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
HEXYLDECANOL (UNII: 151Z7P1317)
CERESIN (UNII: Q1LS2UJO3A)
STEARIC ACID (UNII: 4ELV7Z65AP)
ZINGIBER OFFICINALE (GINGER) ROOT OIL (UNII: SAS9Z1SVUK)
HEXYLDECYL LAURATE (UNII: 0V595C1P6M)
CI 77499 (UNII: XM0M87F357)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PEG-8 (UNII: B697894SGQ)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALUMINA (UNII: LMI26O6933)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
PEG/PPG-15/15 DIMETHICONE (UNII: 184IZ28A2G)
FLAVOR SPICE MINT N&A110589 (UNII: KG6KU384XW)
CI 77491 (UNII: 1K09F3G675)
CI 77492 (UNII: EX438O2MRT)
CETYL DIMETHYLBUTYL ETHER (UNII: 7LAB1GXG9G)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TOCOPHEROL (UNII: R0ZB2556P8)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85394-212-45	4.5 g in 1 CYLINDER; Type 0: Not a Combination Product	05/09/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/09/2022

Labeler - The Maui Medical Group, Inc (077677102)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc		793406000	manufacture(85394-212)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85394-212)