Label: PROTECTOR R PLUS- octinoxate, titanium dioxide, oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 42248-124-01 - Packager: Zenith Medicosm SL
- 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 February 20, 2012
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- Active Ingredient
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Description
Made with plant squalene, marine collagen and hyaluronic acid, intensive cream with double moisturizing control provides an overall reduction of signs of ageing by progressively activating natural defence mechanisms. It strenghtens the moisture barrier and favours the skin regeneration process. Suitable for use on very dry, dehydrated skin with wrinkles and lack of elasticity.
200ml. 6.8 fl. Oz
- Warning
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INGREDIENTS AND APPEARANCE
PROTECTOR R PLUS
octinoxate, titanium dioxide, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42248-124 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 15 mL in 200 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 50 mL in 200 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 12 mL in 200 mL Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE (UNII: LMI26O6933) PROPYLPARABEN (UNII: Z8IX2SC1OH) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) METHYLPARABEN SODIUM (UNII: CR6K9C2NHK) WATER (UNII: 059QF0KO0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) WHITE WAX (UNII: 7G1J5DA97F) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW) (UNII: ZR28QKN0WT) CARBOMER 934 (UNII: Z135WT9208) IMIDUREA (UNII: M629807ATL) EDETATE DISODIUM (UNII: 7FLD91C86K) METHYLPARABEN (UNII: A2I8C7HI9T) COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) (2-CARBETHOXYETHYL)DIETHOXY(METHYL)SILANE (UNII: N28HAC3H5P) HYDROXYPROLINE (UNII: RMB44WO89X) ASPARTIC ACID (UNII: 30KYC7MIAI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42248-124-01 200 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/01/2011 Labeler - Zenith Medicosm SL (464239694) Registrant - Zenith Medicosm SL (464239694) Establishment Name Address ID/FEI Business Operations Zenith Medicosm SL 464239694 manufacture