ALOE SUN SPF28 PA PLUS PLUS- octinoxate spray 
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 7%, ENSULIZOLE 2%

Inactive ingredients:
WATER, C12-15 ALKYL BENZOATE, 4-METHYLBENZYLIDENE CAMPHOR, BUTYLENE GLYCOL, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETEARETH-6 OLIVATE, PEG-7 GLYCERYL COCOATE, ALOE BARBADENSIS LEAF EXTRACT, C12-20 ALKYL GLUCOSIDE, C14-22 ALCOHOLS, DIMETHICONE, MALPIGHIA GLABRA(ACEROLA) FRUIT EXTRACT, GLYCERIN, SODIUM HYDROXIDE, CELLULOSE GUM, CETEARYL OLIVATE, SORBITAN OLIVATE, MICROCRYSTALLINE CELLULOSE, DISODIUM EDTA, ETHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, METHYLPARABEN, PROPYLPARABEN, 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

ALOE SUN  SPF28 PA PLUS PLUS
octinoxate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-019
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 mL  in 100 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ENZACAMENE (UNII: 8I3XWY40L9)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BEMOTRIZINOL (UNII: PWZ1720CBH)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
C14-22 ALCOHOLS (UNII: B1K89384RJ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76214-019-01100 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: cb4b69e6-01fe-4955-a69c-16ff4169822c
Set id: a1f76361-23fa-4ef8-96d6-eaf3a6b6540c
Version: 1
Effective Time: 20110908
 
SKINFOOD CO., LTD.