TINTED MINERAL SUNSCREEN STICK- titanium dioxide, zinc oxide stick

Tinted Mineral Sunscreen Stick by

Drug Labeling and Warnings

Tinted Mineral Sunscreen Stick by is a Otc medication manufactured, distributed, or labeled by MILESTHETICS LLC, 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

TINTED MINERAL SUNSCREEN STICK 
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85888-220(NDC:58892-220)
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
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
PEG/PPG-15/15 DIMETHICONE (UNII: 184IZ28A2G)
CI 77492 (UNII: EX438O2MRT)
CERESIN (UNII: Q1LS2UJO3A)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
STEARIC ACID (UNII: 4ELV7Z65AP)
HEXYLDECYL LAURATE (UNII: 0V595C1P6M)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
ZINGIBER OFFICINALE (GINGER) ROOT OIL (UNII: SAS9Z1SVUK)
CETYL DIMETHYLBUTYL ETHER (UNII: 7LAB1GXG9G)
CI 77491 (UNII: 1K09F3G675)
CI 77499 (UNII: XM0M87F357)
HEXYLDECANOL (UNII: 151Z7P1317)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALUMINA (UNII: LMI26O6933)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CITRIC ACID (UNII: 2968PHW8QP)
PEG-8 (UNII: B697894SGQ)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
TOCOPHEROL (UNII: R0ZB2556P8)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85888-220-30	30 g in 1 CYLINDER; Type 0: Not a Combination Product	07/09/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/09/2025

Labeler - MILESTHETICS LLC (044362426)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85888-220)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing INC		793406000	manufacture(85888-220)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85888-220)