Label: ZINC OXIDE, TITANIUM DIOXIDE cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70798-415-22 - Packager: MATCHCo Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated May 12, 2016
If you are a consumer or patient please visit this version.
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- STATEMENT OF IDENTITY SECTION
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INDICATIONS AND USAGE SECTION
Uses
- helps prevent sunburn
- higher SPF gives more sunburn protection
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
- OTHER SAFETY INFORMATION
- OTC - ACTIVE INGREDIENT SECTION
- OTC - STOP USE SECTION
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
ZINC OXIDE, TITANIUM DIOXIDE
zinc oxide, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70798-415 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.9 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 5.9 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:70798-415-22 30 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 07/11/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 07/11/2016 Labeler - MATCHCo Inc. (079937374) Registrant - MATCHCo Inc. (079937374) Establishment Name Address ID/FEI Business Operations MATCHCo Inc. 079937374 manufacture(70798-415)
