TITANIUM DIOXIDE, ZINC OXIDE- on the go sunscreen stick stick

Titanium Dioxide, Zinc Oxide by

Drug Labeling and Warnings

Titanium Dioxide, Zinc Oxide by is a Otc medication manufactured, distributed, or labeled by REVIVE IN SOLANO, 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

TITANIUM DIOXIDE, ZINC OXIDE 
on the go sunscreen stick stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85628-220(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
ALUMINA (UNII: LMI26O6933)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CI 77491 (UNII: 1K09F3G675)
CI 77499 (UNII: XM0M87F357)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
HEXYLDECANOL (UNII: 151Z7P1317)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
STEARIC ACID (UNII: 4ELV7Z65AP)
CITRIC ACID (UNII: 2968PHW8QP)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
HEXYLDECYL LAURATE (UNII: 0V595C1P6M)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG-8 (UNII: B697894SGQ)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
TOCOPHEROL (UNII: R0ZB2556P8)
CI 77492 (UNII: EX438O2MRT)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
ZINGIBER OFFICINALE (GINGER) ROOT OIL (UNII: SAS9Z1SVUK)
CETYL DIMETHYLBUTYL ETHER (UNII: 7LAB1GXG9G)
PEG/PPG-15/15 DIMETHICONE (UNII: 184IZ28A2G)
CERESIN (UNII: Q1LS2UJO3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85628-220-30	30 g in 1 CYLINDER; Type 0: Not a Combination Product	07/13/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/13/2023

Labeler - REVIVE IN SOLANO (025770696)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85628-220)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing INC		793406000	manufacture(85628-220)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85628-220)