SHEER TINTED SUNSCREEN STICK- titanium dioxide, zinc oxide stick

Sheer Tinted Sunscreen Stick by

Drug Labeling and Warnings

Sheer Tinted Sunscreen Stick by is a Otc medication manufactured, distributed, or labeled by The Maui Medical Group, Inc, 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

SHEER TINTED SUNSCREEN STICK 
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85394-220(NDC:58892-220)
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
ALUMINA (UNII: LMI26O6933)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CETYL DIMETHYLBUTYL ETHER (UNII: 7LAB1GXG9G)
CITRIC ACID (UNII: 2968PHW8QP)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX (UNII: 42DG15CHXV)
HEXYLDECYL LAURATE (UNII: 0V595C1P6M)
CI 77491 (UNII: 1K09F3G675)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CERESIN (UNII: Q1LS2UJO3A)
ZINGIBER OFFICINALE (GINGER) ROOT OIL (UNII: SAS9Z1SVUK)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
HEXYLDECANOL (UNII: 151Z7P1317)
CI 77492 (UNII: EX438O2MRT)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
PEG/PPG-15/15 DIMETHICONE (UNII: 184IZ28A2G)
CI 77499 (UNII: XM0M87F357)
PEG-8 (UNII: B697894SGQ)
TOCOPHEROL (UNII: R0ZB2556P8)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85394-220-30	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 - The Maui Medical Group, Inc (077677102)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85394-220)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc		793406000	manufacture(85394-220)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85394-220)