TINTED LIP SHADE SUNSCREEN- titanium dioxide, zinc oxide stick

Tinted Lip Shade Sunscreen by

Drug Labeling and Warnings

Tinted Lip Shade Sunscreen by is a Otc medication manufactured, distributed, or labeled by BLISS BEAUTY 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

TINTED LIP SHADE SUNSCREEN 
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85712-212(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
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
ZINGIBER OFFICINALE (GINGER) ROOT OIL (UNII: SAS9Z1SVUK)
CERESIN (UNII: Q1LS2UJO3A)
CI 77492 (UNII: EX438O2MRT)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
CETYL DIMETHYLBUTYL ETHER (UNII: 7LAB1GXG9G)
DIPROPYLENE GLYCOL CAPRATE/CAPRYLATE DIESTER (UNII: R6G12EY23X)
HEXYLDECANOL (UNII: 151Z7P1317)
HEXYLDECYL LAURATE (UNII: 0V595C1P6M)
CI 77499 (UNII: XM0M87F357)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
PEG-8 (UNII: B697894SGQ)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ALUMINA (UNII: LMI26O6933)
PEG/PPG-15/15 DIMETHICONE (UNII: 184IZ28A2G)
CI 77491 (UNII: 1K09F3G675)
CITRIC ACID (UNII: 2968PHW8QP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ASCORBYL PALMITATE (UNII: QN83US2B0N)

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: 85712-212-45	1 in 1 CARTON	06/16/2023
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	06/16/2023

Labeler - BLISS BEAUTY LLC (120490950)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85712-212)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing INC		793406000	manufacture(85712-212)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85712-212)