CARROT SUN SPF30 PA PLUS PLUS- octinoxate cream 
SKINFOOD CO., LTD.

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.

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Drug Facts

Active ingredients: OCTINOXATE 6%, OCTISALATE 5%, TITANIUM DIOXIDE 3.4%, AVOBENZONE 1.5%

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: Protects skin from UV rays.

Warnings:
For external use only. Avoid contact with eyes.
Discontinue use if signs of irritation appear.

Keep out of reach of children:
Keep out of reach of children.

Indication and usage:
After your daily skincare regimen, apply liberally onto your face, neck, arms, legs, and other areas that are easily exposed to UV sunlight. Avoid the eye area.

Dosage and administration:
For best results, apply at least 15 to 20 minutes before sun exposure.
Reapply frequently while out in the sun.

Image of carton

CARROT SUN  SPF30 PA PLUS PLUS
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-014
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3 g  in 50 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.5 g  in 50 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE1.7 g  in 50 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.75 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76214-014-0150 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/01/2011
Labeler - SKINFOOD CO., LTD. (690324173)
Registrant - SKINFOOD CO., LTD. (690324173)
Establishment
NameAddressID/FEIBusiness Operations
SKINFOOD CO., LTD.690324173manufacture

Revised: 9/2011
Document Id: 1413e5f0-f500-4104-b733-9512050efe31
Set id: ede17cd9-02be-4ed4-aaf9-cb85afc547fb
Version: 1
Effective Time: 20110907
 
SKINFOOD CO., LTD.