TINTED LIP BALM- titanium dioxide, zinc oxide stick

Tinted Lip Balm by

Drug Labeling and Warnings

Tinted Lip Balm by is a Otc medication manufactured, distributed, or labeled by Goldberg, Howard S MD 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

TINTED LIP BALM 
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85362-212
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
ASCORBYL PALMITATE (UNII: QN83US2B0N)
PEG/PPG-15/15 DIMETHICONE (UNII: 184IZ28A2G)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
PEG-8 (UNII: B697894SGQ)
CITRIC ACID (UNII: 2968PHW8QP)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
HEXYLDECANOL (UNII: 151Z7P1317)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
CERESIN (UNII: Q1LS2UJO3A)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
CETYL DIMETHYLBUTYL ETHER (UNII: 7LAB1GXG9G)
CI 77491 (UNII: 1K09F3G675)
CI 77499 (UNII: XM0M87F357)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
ZINGIBER OFFICINALE (GINGER) ROOT OIL (UNII: SAS9Z1SVUK)
ALUMINA (UNII: LMI26O6933)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
HEXYLDECYL LAURATE (UNII: 0V595C1P6M)
CI 77492 (UNII: EX438O2MRT)
DIPROPYLENE GLYCOL CAPRATE/CAPRYLATE DIESTER (UNII: R6G12EY23X)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)

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: 85362-212-45	4.5 g in 1 CYLINDER; Type 0: Not a Combination Product	01/07/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/07/2025

Labeler - Goldberg, Howard S MD Inc (181591181)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing INC		793406000	manufacture(85362-212)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85362-212)