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 Melinda Menezes, M.D., 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

MINERAL LIP SUNSCREEN 
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85314-212
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	38 mg  in 1 g

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

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: 85314-212-45	4.5 in 1 CYLINDER	09/13/2018
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	09/13/2018

Labeler - Melinda Menezes, M.D., Inc. (022910406)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc		793406000	manufacture(85314-212)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85314-212)