TAKO PORE SEBUM SUN- octocrylene, homosalate, octisalate, avobenzone, octinoxate stick 
TONY MOLY 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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ACTIVE INGREDIENT

Active ingredients: Octocrylene 5.00%, Homosalate 5.00%, Ethylhexyl Salicylate 4.50%, Butyl Methoxydibenzoylmethane 4.00%, Ethylhexyl Methoxycinnamate 3.50%

INACTIVE INGREDIENT

Inactive ingredients:

Dimethicone, Polyethylene, Ethylhexyl Palmitate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Diphenylsiloxy Phenyl Trimethicone, Microcrystalline Wax, Polysilicone-15, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Fragrance, Tocopheryl Acetate, Caprylyl Glycol, Eclipta Prostrata Extract, Melia Azadirachta Leaf Extract, Moringa Oleifera Seed Oil, Water, Panthenol, Calamine, Nelumbo Nucifera Flower Water, Sea Water, Centella Asiatica Extract, 1,2-Hexanediol, Algae Extract, Chlorella Vulgaris Extract, Hizikia Fusiforme Extract, Hydrolyzed Collagen

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:

For external use only

Avoid contact with eyes.

Discontinue use if signs of irritation or rashes appear.

Replace the cap after use.

Keep Out of Reach of Children

DESCRIPTION

Uses:

- helps prevent sunburn

- If used as directed with other sun protection measures

Directions:

Take an appropriate amount, evenly apply to face and body anywhere to be exposed to UV rays. Use as the last step of basic skin care.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

TAKO PORE SEBUM SUN 
octocrylene, homosalate, octisalate, avobenzone, octinoxate stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-326
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene0.47 g  in 9.5 g
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate0.47 g  in 9.5 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.42 g  in 9.5 g
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone0.38 g  in 9.5 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate0.33 g  in 9.5 g
Inactive Ingredients
Ingredient NameStrength
Dimethicone (UNII: 92RU3N3Y1O)  
Ethylhexyl Palmitate (UNII: 2865993309)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59078-326-021 in 1 CARTON03/01/2018
1NDC:59078-326-019.5 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2018
Labeler - TONY MOLY CO.,LTD (688216798)
Registrant - TONY MOLY CO.,LTD (688216798)
Establishment
NameAddressID/FEIBusiness Operations
TONY MOLY CO.,LTD688216798manufacture(59078-326)

Revised: 4/2018
Document Id: 6c95982c-c922-4815-95c0-897605186cc2
Set id: 00bf17c2-d1fb-4f1f-b30b-519aa80fef5c
Version: 1
Effective Time: 20180404
 
TONY MOLY CO.,LTD