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 CAPE COD SKIN CARE CO. 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: 85627-212
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
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CETYL DIMETHYLBUTYL ETHER (UNII: 7LAB1GXG9G)
CI 77492 (UNII: EX438O2MRT)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIPROPYLENE GLYCOL CAPRATE/CAPRYLATE DIESTER (UNII: R6G12EY23X)
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX (UNII: 42DG15CHXV)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ZINGIBER OFFICINALE (GINGER) ROOT OIL (UNII: SAS9Z1SVUK)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
CITRIC ACID (UNII: 2968PHW8QP)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HEXYLDECYL LAURATE (UNII: 0V595C1P6M)
CI 77499 (UNII: XM0M87F357)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALUMINA (UNII: LMI26O6933)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
CERESIN (UNII: Q1LS2UJO3A)
PEG-8 (UNII: B697894SGQ)
TOCOPHEROL (UNII: R0ZB2556P8)
PEG/PPG-15/15 DIMETHICONE (UNII: 184IZ28A2G)
HEXYLDECANOL (UNII: 151Z7P1317)
CI 77491 (UNII: 1K09F3G675)

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: 85627-212-45	4.5 in 1 CYLINDER	12/06/2023
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	12/06/2023

Labeler - CAPE COD SKIN CARE CO. INC. (042396858)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc		793406000	manufacture(85627-212)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85627-212)