LIP BALM- titanium dioxide, zinc oxide stick

Lip Balm by

Drug Labeling and Warnings

Lip Balm by is a Otc medication manufactured, distributed, or labeled by PATRICIA SOLIS MAKEUP ARTIST, 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

LIP BALM 
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85649-212(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
HEXYLDECYL LAURATE (UNII: 0V595C1P6M)
CI 77491 (UNII: 1K09F3G675)
CI 77492 (UNII: EX438O2MRT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PEG-8 (UNII: B697894SGQ)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
STEARIC ACID (UNII: 4ELV7Z65AP)
CERESIN (UNII: Q1LS2UJO3A)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
HEXYLDECANOL (UNII: 151Z7P1317)
CI 77499 (UNII: XM0M87F357)
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX (UNII: 42DG15CHXV)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
TOCOPHEROL (UNII: R0ZB2556P8)
DIPROPYLENE GLYCOL CAPRATE/CAPRYLATE DIESTER (UNII: R6G12EY23X)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CETYL DIMETHYLBUTYL ETHER (UNII: 7LAB1GXG9G)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
PEG/PPG-15/15 DIMETHICONE (UNII: 184IZ28A2G)
CITRIC ACID (UNII: 2968PHW8QP)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ZINGIBER OFFICINALE (GINGER) ROOT OIL (UNII: SAS9Z1SVUK)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
ALUMINA (UNII: LMI26O6933)

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: 85649-212-45	1 in 1 CARTON	06/03/2021
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	06/03/2021

Labeler - PATRICIA SOLIS MAKEUP ARTIST, LLC (067573417)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85649-212)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(85649-212)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85649-212)