MINERAL LIP SUNSCREEN TINTED- titanium dioxide, zinc oxide stick

Mineral Lip Sunscreen Tinted by

Drug Labeling and Warnings

Mineral Lip Sunscreen Tinted by is a Otc medication manufactured, distributed, or labeled by DR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST, 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 TINTED 
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85634-212(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
CETYL DIMETHYLBUTYL ETHER (UNII: 7LAB1GXG9G)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
HEXYLDECYL LAURATE (UNII: 0V595C1P6M)
STEARIC ACID (UNII: 4ELV7Z65AP)
ZINGIBER OFFICINALE (GINGER) ROOT OIL (UNII: SAS9Z1SVUK)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CITRIC ACID (UNII: 2968PHW8QP)
CI 77499 (UNII: XM0M87F357)
CERESIN (UNII: Q1LS2UJO3A)
PEG-8 (UNII: B697894SGQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
PEG/PPG-15/15 DIMETHICONE (UNII: 184IZ28A2G)
HEXYLDECANOL (UNII: 151Z7P1317)
CI 77491 (UNII: 1K09F3G675)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPROPYLENE GLYCOL CAPRATE/CAPRYLATE DIESTER (UNII: R6G12EY23X)
ALUMINA (UNII: LMI26O6933)
CI 77492 (UNII: EX438O2MRT)
TOCOPHEROL (UNII: R0ZB2556P8)

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: 85634-212-45	1 in 1 CARTON	04/11/2023
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	04/11/2023

Labeler - DR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST (123102195)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85634-212)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing INC		793406000	manufacture(85634-212)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85634-212)