Label: NEOVA DNA DAMAGE CONTROL - ACTIVE BROAD SPECTRUM SPF 43- octinoxate, zinc oxide emulsion
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Contains inactivated NDC Code(s)
NDC Code(s): 62362-179-01, 62362-179-89 - Packager: PhotoMedex, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 2, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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Directions
- Apply liberally 15 minutes before sun exposure.
- Reapply:
°After 80 minutes of swimming or sweating.
°Immediately after towel drying.
°At least every two hours.
- Children under 6 months of age: ask a doctor.
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
°Limit time in the sun, especially from 10 a.m. - 2 p.m.
°Wear long-sleeve shirts, pants, hats, and sunglasses.
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Inactive Ingredients
Ascorbyl Palmitate, Butylene Glycol, Citric Acid, Cyclopentasiloxane, Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyldimethicone Crosspolymer, Ergothioneine, Ethyl Hexyl Isononanoate,Iodopropynyl Butylcarbamate, Lauryl PEG-9 Polymethylsiloxyethyl Dimethicone, Lecithin, Microcoous Lysate, Phenoxyethanol, Plankton Extract, Purified Water, Retinyl Palmitate, Sodium Chloride, Sodium Hydroxide, Triethanoxycaprylylsilane.
- Other Information
- Questions or Comments?
- Neova DNA Damage Control Active SPF 433.0 fl. oz. (89mL)
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INGREDIENTS AND APPEARANCE
NEOVA DNA DAMAGE CONTROL - ACTIVE BROAD SPECTRUM SPF 43
octinoxate, zinc oxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62362-179 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 9 g in 100 mL Inactive Ingredients Ingredient Name Strength ASCORBYL PALMITATE (UNII: QN83US2B0N) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) ERGOTHIONEINE (UNII: BDZ3DQM98W) ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM HYDROXIDE (UNII: 55X04QC32I) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62362-179-01 1 in 1 BOX 1 NDC:62362-179-89 89 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/08/2012 Labeler - PhotoMedex, Inc. (054503875) Establishment Name Address ID/FEI Business Operations PhotoMedex, Inc. 054503875 manufacture(62362-179)
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