MINERAL LIP PROTECTION- titanium dioxide, zinc oxide stick

Mineral Lip Protection by

Drug Labeling and Warnings

Mineral Lip Protection by is a Otc medication manufactured, distributed, or labeled by CLEAR SKIN SOLUTIONS, LLC, 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 PROTECTION 
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85563-212
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
ALUMINA (UNII: LMI26O6933)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CITRIC ACID (UNII: 2968PHW8QP)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
ZINGIBER OFFICINALE (GINGER) ROOT OIL (UNII: SAS9Z1SVUK)
CI 77491 (UNII: 1K09F3G675)
CI 77492 (UNII: EX438O2MRT)
CERESIN (UNII: Q1LS2UJO3A)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
DIPROPYLENE GLYCOL CAPRATE/CAPRYLATE DIESTER (UNII: R6G12EY23X)
HEXYLDECYL LAURATE (UNII: 0V595C1P6M)
PEG-8 (UNII: B697894SGQ)
PEG/PPG-15/15 DIMETHICONE (UNII: 184IZ28A2G)
CI 77499 (UNII: XM0M87F357)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETYL DIMETHYLBUTYL ETHER (UNII: 7LAB1GXG9G)
HEXYLDECANOL (UNII: 151Z7P1317)

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: 85563-212-45	4.5 g in 1 CYLINDER; Type 0: Not a Combination Product	07/11/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/11/2019

Labeler - CLEAR SKIN SOLUTIONS, LLC (076140083)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing INC		793406000	manufacture(85563-212)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85563-212)