Label: NEOVA DNA DAMAGE CONTROL - ACTIVE SPF 45- zinc oxide, octinoxate, octisalate emulsion
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Contains inactivated NDC Code(s)
NDC Code(s): 62362-129-02, 62362-129-03 - Packager: PhotoMedex, 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 January 6, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Directions for use:
- Supplied
- Active Ingredients:
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Inactive Ingredients:
Water (Aqua), Cyclopentasiloxane,
Ethyl Hexyl Isononanoate, Micrococcus Lysate, Plankton
Extract, L-ergothioneine, Dimethicone, Dimethicone/
PEG-10/15 Crosspolymer, Lauryl PEG-9 Polymethylsiloxyethyl
Dimethicone, Dimethicone/Vinyl Dimethicone
Crosspolymer, Retinyl Palmitate, Ascorbyl Palmitate
(Vitamin C), Sodium Chloride, Phenoxyethanol, Butylene
Glycol, Iodopropynyl Butylcarbamate, Citric Acid,
Sodium Hydroxide. - Image of package, pouch, and package insert
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INGREDIENTS AND APPEARANCE
NEOVA DNA DAMAGE CONTROL - ACTIVE SPF 45
zinc oxide, octinoxate, octisalate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62362-129 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 8 mL in 100 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 7.5 mL in 100 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 3 mL in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Cyclomethicone 5 (UNII: 0THT5PCI0R) Ethylhexyl Isononanoate (UNII: I6KB4GE3K4) Micrococcus Luteus (UNII: LV6L29Z6AX) Ergothioneine (UNII: BDZ3DQM98W) Dimethicone (UNII: 92RU3N3Y1O) Vitamin A Palmitate (UNII: 1D1K0N0VVC) Ascorbyl Palmitate (UNII: QN83US2B0N) Sodium Chloride (UNII: 451W47IQ8X) Phenoxyethanol (UNII: HIE492ZZ3T) Butylene Glycol (UNII: 3XUS85K0RA) Iodopropynyl Butylcarbamate (UNII: 603P14DHEB) Citric Acid (UNII: 2968PHW8QP) Sodium Hydroxide (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62362-129-03 1 in 1 POUCH 1 NDC:62362-129-02 2 mL in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/06/2012 Labeler - PhotoMedex, Inc. (054503875) Establishment Name Address ID/FEI Business Operations PhotoMedex, Inc. 054503875 manufacture