OSEQUE ZSOLE DUAL SUN BLOCK- octinoxate avobenzone bisoctrizole spray

OSEQUE Zsole Dual Sun Block by

Drug Labeling and Warnings

OSEQUE Zsole Dual Sun Block by is a Other medication manufactured, distributed, or labeled by SONGHAK CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Octyl Methoxycinnamate 7.5%, Ethylhexyl Salicylate 5%, Avobenzone 2%, Bisoctrizole 0.5%

PURPOSE

Purpose: Sunscreen

INACTIVE INGREDIENT

Inactive Ingredients: Water, Alcohol Denat, Butylene Glycol, Glycerin, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Niacinamide, Isononyl Isononanoate, Glacier Water, Butyloctyl Salicylate, Xanthan Gum, Decyl Glucoside, Disodium EDTA, Methylparaben, Propylparaben, Fragrance

DO NOT USE

Do not use: on wounds, rashes, dermatitis or damaged skin

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately

STOP USE

Stop use: Please stop using this product and contact a dermatologist

1. If allergic reaction or irritation occurs

2. If direct sunlight affects the area as above

WHEN USING

When using this product: Do not use other than directed

WARNINGS

Warnings: For external use only.  Not to be swallowed.  Avoid contact with eyes.  Discontinue use if signs of irritation or rash appear

INSTRUCTIONS FOR USE

Uses: Spray or apply liberally over the face and body 15 minutes prior to sun exposure.  Always ensure total coverage of all sun exposed areas.  Re-apply every 1-2 hours and always after swimming.  For spray type, shake it well before use and spray it evenly at 20cm-30cm apart from face or wherever needed.

For spray type

- shake it well before use

For lotion type

- turn a cap to use

STORAGE AND HANDLING

Storage: Keep in a dry or room temperature area

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OSEQUE ZSOLE DUAL SUN BLOCK 
octinoxate avobenzone bisoctrizole spray

Product Information
Product Type	COSMETIC	Item Code (Source)	59370-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	8.75 g  in 70 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.4 g  in 70 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
NIACINAMIDE (UNII: 25X51I8RD4)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
XANTHAN GUM (UNII: TTV12P4NEE)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	59370-200-01	70 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/01/2014

Labeler - SONGHAK CO., LTD. (688237512)

Registrant - SONGHAK CO., LTD. (688237512)

Establishment
Name	Address	ID/FEI	Business Operations
SONGHAK CO., LTD.		688237512	manufacture(59370-200)