Label: ORCHID SECRET FOUNDATION 21 SPF28 PA PLUS PLUS- titanium dioxide, octinoxate, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51346-032-01 - Packager: NATURE REPUBLIC CO., LTD.
- 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 August 27, 2012
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients:
WATER, CYCLOPENTASILOXANE, TALC, DIPROPYLENE GLYCOL, GLYCERIN, PEG-10 DIMETHICONE, CYCLOMETHICONE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, HEXYLDECYL MYRISTOYL METHYLAMINOPROPIONATE, NIACINAMIDE, PHENYL TRIMETHICONE, IRON OXIDES, BETAINE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE, HEXYL LAURATE, NELUMBO NUCIFERA FLOWER WATER, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, C12-14 PARETH-3, ACRYLATES/DIMETHICONE COPOLYMER, PHENOXYETHANOL, METHICONE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, SILICA, PALMITIC ACID, FRAGRANCE, METHYLPARABEN, PROPYLPARABEN, TOCOPHERYL ACETATE, PULSATILLA KOREANA EXTRACT, USNEA BARBATA (LICHEN) EXTRACT, ZANTHOXYLUM PIPERITUM FRUIT EXTRACT, DIOSPYROS KAKI LEAF EXTRACT, HYDROGENATED LECITHIN, RUBUS FRUTICOSUS (BLACKBERRY) FRUIT EXTRACT, SEA WATER, ACACIA SENEGAL FLOWER/STEM EXTRACT, ARNICA MONTANA FLOWER EXTRACT, CENTAUREA CYANUS FLOWER EXTRACT, DIANTHUS CARYOPHYLLUS FLOWER EXTRACT, FREESIA REFRACTA EXTRACT, IRIS VERSICOLOR EXTRACT, JASMINUM OFFICINALE (JASMINE) FLOWER/LEAF EXTRACT, ZANTEDESCHIA AETHIOPICA FLOWER/STEM EXTRACT,
HYDROGENATED VEGETABLE OIL, ALUMINUM HYDROXIDE, ALUMINUM STEARATE, NEOFINETIA FALCATA CALLUS CULTURE EXTRACT, BUTYLPARABEN, ADENOSINE, SODIUM HYALURONATE, XANTHAN GUM, PEARL POWDER, ALUMINUM SILICATE, LECITHIN - PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- PACKAGE LABEL. PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ORCHID SECRET FOUNDATION 21 SPF28 PA PLUS PLUS
titanium dioxide, octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51346-032 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.76 g in 35 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.05 g in 35 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.66 g in 35 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) TALC (UNII: 7SEV7J4R1U) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51346-032-01 35 mL in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/15/2012 Labeler - NATURE REPUBLIC CO., LTD. (631172020) Registrant - NATURE REPUBLIC CO., LTD. (631172020) Establishment Name Address ID/FEI Business Operations NATURE REPUBLIC CO., LTD. 631172020 manufacture(51346-032)