NON TINTED MINERAL SUNSCREEN STICK- titanium dioxide, zinc oxide cream

Non Tinted Mineral Sunscreen Stick by

Drug Labeling and Warnings

Non Tinted Mineral Sunscreen Stick by is a Otc medication manufactured, distributed, or labeled by BABYFACE LLC, Fragrance Manufacturing INC. 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

NON TINTED MINERAL SUNSCREEN STICK 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85374-219
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
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HEXYLDECYL LAURATE (UNII: 0V595C1P6M)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
PEG-8 (UNII: B697894SGQ)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ZINGIBER OFFICINALE (GINGER) ROOT OIL (UNII: SAS9Z1SVUK)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
CERESIN (UNII: Q1LS2UJO3A)
STEARIC ACID (UNII: 4ELV7Z65AP)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HEXYLDECANOL (UNII: 151Z7P1317)
PEG/PPG-15/15 DIMETHICONE (UNII: 184IZ28A2G)
CETYL DIMETHYLBUTYL ETHER (UNII: 7LAB1GXG9G)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
CITRIC ACID (UNII: 2968PHW8QP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
TOCOPHEROL (UNII: R0ZB2556P8)
ALUMINA (UNII: LMI26O6933)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85374-219-30	30 g in 1 CYLINDER; Type 0: Not a Combination Product	06/19/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/19/2023

Labeler - BABYFACE LLC (045740197)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing INC		793406000	manufacture(85374-219)