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

Mineral Based Sunscreen Stick Tinted by

Drug Labeling and Warnings

Mineral Based Sunscreen Stick Tinted by is a Otc medication manufactured, distributed, or labeled by KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION, 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 BASED SUNSCREEN STICK TINTED 
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81679-220
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
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CERESIN (UNII: Q1LS2UJO3A)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CI 77492 (UNII: EX438O2MRT)
CI 77491 (UNII: 1K09F3G675)
CI 77499 (UNII: XM0M87F357)
CETYL DIMETHYLBUTYL ETHER (UNII: 7LAB1GXG9G)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
ALUMINA (UNII: LMI26O6933)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
STEARIC ACID (UNII: 4ELV7Z65AP)
PEG-8 (UNII: B697894SGQ)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CITRIC ACID (UNII: 2968PHW8QP)
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX (UNII: 42DG15CHXV)
HEXYLDECANOL (UNII: 151Z7P1317)
HEXYLDECYL LAURATE (UNII: 0V595C1P6M)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PEG/PPG-15/15 DIMETHICONE (UNII: 184IZ28A2G)
TOCOPHEROL (UNII: R0ZB2556P8)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ZINGIBER OFFICINALE (GINGER) ROOT OIL (UNII: SAS9Z1SVUK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81679-220-30	30 g in 1 CYLINDER; Type 0: Not a Combination Product	07/10/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/10/2024

Labeler - KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION (792310955)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(81679-220)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(81679-220)