ALOE SOOTHING SUNCREAM- octinoxate,titanium dioxide cream 
COSRX inc.

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

Ethylhexyl Methoxycinnamate 7.20%
Titanium Dioxide 1.48%

Sunscreen

Helps prevent sunburn

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours

Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses

Ask a doctor to use for children under 6 months

For external use only.
Do not use on damaged or broken skin.
When using this product, keep out of eyes. Rinse with water to remove.
Stop using and ask a doctor if rash occurs.

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Water, Glycerin, Propylene Glycol, Cyclopentasiloxane, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Phenylbenzimidazole Sulfonic Acid, Dicaprylyl Carbonate, Isoamyl P-Methoxycinnamate, Potassium Cetyl Phosphate, Alcohol, Dimethicone, Glyceryl Stearate, Butylene Glycol, C14-22 Alcohols, Polymethyl Methacrylate, Cetearyl Alcohol, Aloe Arborescens Leaf Extract, Dipotassium Glycyrrhizate, Tocopheryl Acetate, Peg-100 Stearate, Silica, C12-20 Alkyl Glucoside, Dimethicone/Vinyl Dimethicone Crosspolymer, Aluminum Hydroxide, Stearic Acid, Caprylyl Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Xanthan Gum, Triethanolamine, Sodium Hydroxide, Fragrance, Phenoxyethanol, Disodium Edta

image description

ALOE SOOTHING SUNCREAM 
octinoxate,titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70319-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.6 mg  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.74 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BEMOTRIZINOL (UNII: PWZ1720CBH)  
ENSULIZOLE (UNII: 9YQ9DI1W42)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
AMILOXATE (UNII: 376KTP06K8)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
ALCOHOL (UNII: 3K9958V90M)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
C14-22 ALCOHOLS (UNII: B1K89384RJ)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PEG-100 STEARATE (UNII: YD01N1999R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TROLAMINE (UNII: 9O3K93S3TK)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70319-005-021 in 1 PACKAGE12/18/201705/22/2018
1NDC:70319-005-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/18/201705/22/2018
Labeler - COSRX inc. (689516893)
Registrant - COSRX inc. (689516893)
Establishment
NameAddressID/FEIBusiness Operations
Coreana Cosmetics Co Ltd687855411manufacture(70319-005)

Revised: 5/2018
 
COSRX inc.