BROCCOLI SUN SPF42 PA PLUS 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.

----------

Drug Facts

Active ingredients: OCTINOXATE 5%, OCTISALATE 5%, ZINC OXIDE 3.8%, TITANIUM DIOXIDE 2.87%

Inactive ingredients:
WATER, CYCLOPENTASILOXANE, C12-15 ALKYL BENZOATE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, DIETHYLHEXYL CARBONATE, ISOAMYL p-METHOXYCINNAMATE, CETYL CAPRYLATE, DIMETHICONE, CYCLOHEXASILOXANE, CETYL PEG/PPG-10/1 DIMETHICONE, STEARALKONIUM HECTORITE, POLYGLYCERYL-6 POLYHYDROXYSTEARATE,
PEG-30 DIPOLYHYDROXYSTEARATE, SODIUM CHLORIDE, PEG-10 DIMETHICONE, OZOKERITE, PROPYLENE CARBONATE, POLYGLYCERYL-4 ISOSTEARATE, SORBITAN SESQUIOLEATE, ALCOHOL DENAT., HEXYL LAURATE, SORBITAN OLIVATE, TRIMETHOXYCAPRYLYLSILANE, DIMETHICONE, ALOE BARBADENSIS LEAF EXTRACT, BRASSICA OLERACEA ITALICA (BROCCOLI) EXTRACT, BUTYLENE GLYCOL, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, PORTULACA OLERACEA EXTRACT, PROPYLENE GLYCOL, DISODIUM EDTA, METHYLPARABEN, BUTYLPARABEN, FRAGRANCE

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: Use at the end of your daily skincare regimen. Apply liberally onto face and body before sun exposure avoiding 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 bottle

BROCCOLI SUN  SPF42 PA PLUS PLUS PLUS
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-018
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.5 mL  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.5 mL  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE1.9 mL  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE1.44 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
BEMOTRIZINOL (UNII: PWZ1720CBH)  
DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)  
CETYL OCTANOATE (UNII: 418Q5V6PLJ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BROCCOLI (UNII: UOI4FT57BZ)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
PURSLANE (UNII: M6S840WXG5)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76214-018-0150 mL in 1 BOTTLE
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: 3d60ff48-3b2a-4ead-9122-980f52a42be1
Set id: be7ccf24-d63e-4f3f-9d7d-8e2ee8e691e6
Version: 1
Effective Time: 20110908
 
SKINFOOD CO., LTD.