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 HALEM DERMATOLOGY PLLC, 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 LIP SUNSCREEN 
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85413-212(NDC:58892-212)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	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
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
PEG/PPG-15/15 DIMETHICONE (UNII: 184IZ28A2G)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CI 77491 (UNII: 1K09F3G675)
CI 77492 (UNII: EX438O2MRT)
CI 77499 (UNII: XM0M87F357)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ZINGIBER OFFICINALE (GINGER) ROOT OIL (UNII: SAS9Z1SVUK)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CERESIN (UNII: Q1LS2UJO3A)
HEXYLDECANOL (UNII: 151Z7P1317)
ALUMINA (UNII: LMI26O6933)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CETYL DIMETHYLBUTYL ETHER (UNII: 7LAB1GXG9G)
CITRIC ACID (UNII: 2968PHW8QP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPROPYLENE GLYCOL CAPRATE/CAPRYLATE DIESTER (UNII: R6G12EY23X)
TOCOPHEROL (UNII: R0ZB2556P8)
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX (UNII: 42DG15CHXV)
HEXYLDECYL LAURATE (UNII: 0V595C1P6M)
PEG-8 (UNII: B697894SGQ)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85413-212-45	1 in 1 CYLINDER	01/11/2023
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	01/11/2023

Labeler - HALEM DERMATOLOGY PLLC (096071438)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85413-212)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(85413-212)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85413-212)