UV SHIELD SPF 42- octinoxate liquid

UV Shield SPF 42 by

Drug Labeling and Warnings

UV Shield SPF 42 by is a Otc medication manufactured, distributed, or labeled by IASO Inc, Kolmar Korea Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

active ingredient: ethylhexyl methoxycinnamate

INACTIVE INGREDIENT

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

PURPOSE

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 CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

Use before when exposed by the sun

WARNINGS

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

DOSAGE & ADMINISTRATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UV SHIELD SPF 42 
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75847-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75847-0001-1	70 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/12/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/09/2011

Labeler - IASO Inc (688771690)

Registrant - IASO Inc (688771690)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd		689512611	manufacture(75847-0001)