UV SHIELD SPF 42- octinoxate liquid 
IASO Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts

active ingredient: ethylhexyl methoxycinnamate

Inactive ingredients: water, cyclomethicone, titanium dioxide, alcohol, ethylhexyl salicylate, butylene glycol, zinc oxide, dicaprylyl carbonate, talc, sodium chloride, methylparaben, centella asiatica extract

Silky and extremely lightweight, this non-greasy formula smoothes on an invisible veil of UVA/UVB prevention, while natural plant extracts help soothe and repair the skin. Very water-resistant for lasting protection.

keep out of reach of the children

Use before when exposed by the sun

do not use when you feel itching
do not swallow
clean the skin before use

Shake well and apply evenly before sunning
Reapply frequently, and after swimming, perspiring or toweling off

package label
UV SHIELD SPF 42 
octinoxate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75847-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALCOHOL (UNII: 3K9958V90M)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
OCTISALATE (UNII: 4X49Y0596W)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
TALC (UNII: 7SEV7J4R1U)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75847-0001-170 mL in 1 BOTTLE; Type 0: Not a Combination Product03/12/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/09/2011
Labeler - IASO Inc (688771690)
Registrant - IASO Inc (688771690)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co., Ltd689512611manufacture(75847-0001)

Revised: 3/2018
Document Id: 666977f4-3e4d-1fff-e053-2a91aa0a5c44
Set id: d1124084-101e-41b6-a36b-ab28235afc61
Version: 2
Effective Time: 20180302
 
IASO Inc