TIMELESS FERMENT SANIL SUN- octinoxate, octisalate, ensulizole, avobenzone cream

TIMELESS FERMENT SANIL SUN by

Drug Labeling and Warnings

TIMELESS FERMENT SANIL SUN by is a Otc medication manufactured, distributed, or labeled by TONYMOLY CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient: Ethylhexyl Methoxycinnamate 5.5%, Ethylhexyl Salicylate 5.0%, Phenylbenzimidazole Sulfonic Acid 4.0%, Butyl Methoxydibenzoylmethane 3.0%

INACTIVE INGREDIENT

Inactive Ingredient: Water, Snail Secretion Filtrate, Butylene Glycol, Methyl Methacrylate Crosspolymer, C12-15 Alkyl Benzoate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Polymethylsilsesquioxane, Arbutin, Glyceryl Stearate, Cetearyl Olivate, Sorbitan Olivate, Cetearyl Alcohol, Sodium Hydroxide, Dimethicone, PEG-100 Stearate, Polyacrylate-13, Caprylyl Glycol, Panthenol, Polyisobutene, Ethylhexylglycerin, Tocopheryl Acetate, Citrus Limon (Lemon) Peel Oil, Sorbitan Stearate, Chamaecyparis Obtusa Water, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, BHT, 1,2-Hexanediol, Sorbitan Isostearate, Polysorbate 20, Glycerin, Adenosine, Imperata Cylindrica Root Extract, Citrus aurantium dulcis (orange) peel oil, Disodium EDTA, Opuntia Ficus-Indica Extract, Citrus Aurantifolia (Lime) Oil, Propanediol, Pinus Sylvestris Leaf Oil, PEG-8, Eucalyptus Globulus Leaf Oil, Phenoxyethanol, Centella Asiatica Extract, Carbomer, Carica papaya (papaya) fruit Extract, Aloe Barbadensis Leaf Juice, Beta-Glucan, Potassium sorbate, Sodium Benzoate

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: For external use only. When using this product do not get into eyes. Stop use and ask a doctor if rash occurs. Do not use on - deep puncture wounds - animal bites - serious burns Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

DESCRIPTION

Use: Helps prevent and relieve chapped or cracked skin.

Directions: - Clean the skin thoroughly before using - Apply in daily skin care routine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TIMELESS FERMENT SANIL SUN 
octinoxate, octisalate, ensulizole, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59078-310
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	2.75 g  in 50 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	2.50 g  in 50 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	2.00 g  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.50 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59078-310-02	1 in 1 CARTON	05/01/2016
1	NDC: 59078-310-01	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2016

Labeler - TONYMOLY CO.,LTD (688216798)

Registrant - TONYMOLY CO.,LTD (688216798)

Establishment
Name	Address	ID/FEI	Business Operations
TONYMOLY CO.,LTD		688216798	manufacture(59078-310)