MINERAL SUNSCREEN LIP- titanium dioxide, zinc oxide stick

Mineral Sunscreen Lip by

Drug Labeling and Warnings

Mineral Sunscreen Lip by is a Otc medication manufactured, distributed, or labeled by Glow Advanced Skin and Body Care, LLC, Custom Analytics LLC, Fragrance Manufacturing Inc., Fallien Cosmeceuticals Ltd.. 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 SUNSCREEN LIP 
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85372-212(NDC:58892-212)
Route of Administration	TOPICAL

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

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

Product Characteristics
Color		Score
Shape		Size
Flavor	KIWI, LIME	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85372-212-45	1 in 1 CARTON	05/13/2022
1		4.5 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/13/2022

Labeler - Glow Advanced Skin and Body Care, LLC (042558316)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85372-212)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(85372-212)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85372-212)