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

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 Hirschman, Kristina, 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

NON TINTED MINERAL SUNSCREEN STICK 
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85414-219
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	55 mg  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85414-219-30	30 g in 1 CYLINDER; Type 0: Not a Combination Product	11/08/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/08/2023

Labeler - Hirschman, Kristina (117585491)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc		793406000	manufacture(85414-219)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85414-219)