Label: OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30- octinoxate, octisalate, oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 45124-001-05 - Packager: Oscar de la Renta LLC
- 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 April 11, 2012
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- Drug Facts
- Active ingredients
- Use
- Warnings
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- Other information
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Inactive ingredients
WATER, ISODECYL NEOPENTANOATE, GLYCERIN, FRAGRANCE, CETEARYL GLUCOSIDE, CETEARYL ALCOHOL, GLYCERYL STEARATE, POTASSIUM CETYL PHOSPHATE, COCOGLYCERIDES, PHENOXYETHANOL, CYCLOPENTASILOXANE, SODIUM POLYACRYLATE, CAPRYLYL GLYCOL, HEXYL CINNAMAL, BENZYL SALICYLATE, OAT (AVENA SATIVA) KERNEL EXTRACT, LIMONENE, SORBIC ACID, BHT, HYDROXYCITRONELLOL, CYCLOHEXASILOXANE, LINALOOL, CITRONELLOL, GERANIOL, ETHYLHEXYLLAURATE, COCOYL HYDROLYZED WHEAT PROTEIN, HYDROLYZED SOY PROTEIN
- Purpose
- PRINCIPAL DISPLAY PANEL
- Oscar de la Renta Moisturizing Sunscreen Cream SPF 30 120ml/5 Fl OZ (45124-001-05)
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INGREDIENTS AND APPEARANCE
OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30
octinoxate, octisalate, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45124-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mL in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) GLYCERIN (UNII: PDC6A3C0OX) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) COCO-GLYCERIDES (UNII: ISE9I7DNUG) PHENOXYETHANOL (UNII: HIE492ZZ3T) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) CAPRYLYL GLYCOL (UNII: 00YIU5438U) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) BENZYL SALICYLATE (UNII: WAO5MNK9TU) OAT (UNII: Z6J799EAJK) SORBIC ACID (UNII: X045WJ989B) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) HYDROXYCITRONELLOL (UNII: R0B4U2I48W) CYCLOMETHICONE 6 (UNII: XHK3U310BA) LINALOOL, (+/-)- (UNII: D81QY6I88E) GERANIOL (UNII: L837108USY) ETHYLHEXYL LAURATE (UNII: 8J6M396U72) SOY PROTEIN (UNII: R44IWB3RN5) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45124-001-05 1 in 1 CARTON 1 120 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/11/2012 Labeler - Oscar de la Renta LLC (071007918) Establishment Name Address ID/FEI Business Operations Suite K Value Added Services LLC 036822144 manufacture