ZINC OXIDE, TITANIUM DIOXIDE- zinc oxide, titanium dioxide cream 
MATCHCo Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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STATEMENT OF IDENTITY SECTION

Drug Facts

Active ingredients Purpose

Titanium Dioxide 4.0% Sunscreen

Zinc Oxide 5.9% Sunscreen

INDICATIONS AND USAGE SECTION

Uses

Warnings

For external use only

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

WARNINGS SECTION

Warnings

For external use only

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

OTHER SAFETY INFORMATION

Other information

protect the product in this container from excessive heat and direct sun

OTC - ACTIVE INGREDIENT SECTION

Active ingredients Purpose

Titanium Dioxide 4.9% Sunscreen

Zinc Oxide 5.9% Sunscreen

OTC - STOP USE SECTION

Stop use and ask doctor if rash occurs.

Principal Display Panel

Dist. By.

MATCHCo, Inc

Santa Monica, CA 90401

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ZINC OXIDE, TITANIUM DIOXIDE 
zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70798-415
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.9 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.9 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
MORUS ALBA LEAF (UNII: M8YIA49Q2P)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CERAMIDE 2 (UNII: C04977SRJ5)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
LEVOMENOL (UNII: 24WE03BX2T)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
NYLON-12 (UNII: 446U8J075B)  
GLYCERIN (UNII: PDC6A3C0OX)  
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
TOCOTRIENOLS (UNII: KP2MW85SSQ)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CYCLOMETHICONE 4 (UNII: CZ227117JE)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70798-415-2230 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/11/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/11/2016
Labeler - MATCHCo Inc. (079937374)
Registrant - MATCHCo Inc. (079937374)
Establishment
NameAddressID/FEIBusiness Operations
MATCHCo Inc.079937374manufacture(70798-415)

Revised: 5/2016
Document Id: 32aa75a5-49b4-35ab-e054-00144ff88e88
Set id: 32aa75a5-49b3-35ab-e054-00144ff88e88
Version: 1
Effective Time: 20160512
 
MATCHCo Inc.