Label: CARROT SUN SPF30 PA PLUS PLUS- octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 76214-014-01 - Packager: SKINFOOD 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 September 7, 2011
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients:
WATER, PROPYLENE GLYCOL, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, ISOAMYL p-METHOXYCINNAMATE, ISOPROPYL MYRISTATE, CETYL ALCOHOL, POLYSORBATE 80, DIETHYLHEXYL CARBONATE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, POTASSIUM CETYL PHOSPHATE, GLYCERYL STEARATE, PEG-100 STEARATE, POLYGLYCERYL-6 POLYHYDROXYSTEARATE, CAPRYLYL GLYCOL, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ISOHEXADECANE, ALUMINUM HYDROXIDE, STEARIC ACID, BAMBUSA TEXTILIS STEM EXTRACT, BETA-GLUCAN, CITRUS GRANDIS (GRAPEFRUIT) SEED EXTRACT, GLYCERIN, PINUS PALUSTRIS LEAF EXTRACT, TRIDECETH-6, ETHYLHEXYL STEARATE, SODIUM POLYACRYLATE, DAUCUS CAROTA SATIVA (CARROT) ROOT EXTRACT, TRIMETHOXYCAPRYLYLSILANE, BHT, DISODIUM EDTA, TOCOPHERYL ACETATE, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER OIL, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, CITRUS AURANTIUM DULCIS (ORANGE) OIL, CITRUS MEDICA LIMONUM (LEMON) FRUIT OIL, FOENICULUM VULGARE (FENNEL) OIL, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, ZEA MAYS (CORN) OIL - PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CARROT SUN SPF30 PA PLUS PLUS
octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76214-014 Route of Administration CUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3 g in 50 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.5 g in 50 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE 1.7 g in 50 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.75 g in 50 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) CETYL ALCOHOL (UNII: 936JST6JCN) POLYSORBATE 80 (UNII: 6OZP39ZG8H) DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ISOHEXADECANE (UNII: 918X1OUF1E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) GLYCERIN (UNII: PDC6A3C0OX) PINUS PALUSTRIS POLLEN (UNII: E3A7U1HWIO) CARROT (UNII: L56Z1JK48B) TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) EDETATE DISODIUM (UNII: 7FLD91C86K) CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9) BERGAMOT OIL (UNII: 39W1PKE3JI) CITRUS SINENSIS FLOWER OIL (UNII: AJ56JP5TFP) CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED) FENNEL OIL (UNII: 59AAO5F6HT) LAVENDER OIL (UNII: ZBP1YXW0H8) ROSEMARY OIL (UNII: 8LGU7VM393) STARCH, CORN (UNII: O8232NY3SJ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76214-014-01 50 g in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/01/2011 Labeler - SKINFOOD CO., LTD. (690324173) Registrant - SKINFOOD CO., LTD. (690324173) Establishment Name Address ID/FEI Business Operations SKINFOOD CO., LTD. 690324173 manufacture
