DR LEE UV ICE SHIELD- titanium dioxide, octinoxate, zinc oxide, octisalate cream

Dr LeE UV ICE SHIELD by

Drug Labeling and Warnings

Dr LeE UV ICE SHIELD by is a Otc medication manufactured, distributed, or labeled by DRLEECOSMETIC, Seoul cosmetics co.,ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Titanium Dioxide 2.85%, Ethylhexyl Methoxycinnamate 2.14%, Zinc Oxide 1.61%, Ethylhexyl Salicylate 1.43%

INACTIVE INGREDIENT

Inactive ingredients: Butane, Propane, Water, Cyclopentasiloxane, Alcohol Denat., Propanediol, C13-15 Alkane, Bis-Ethylhexyloxyphenol methoxyphenyl triazine, Niacinamide, Talc, 1,2-Hexanedio, Lauryl PEG-8 Dimethicone, Centella Asiatica Leaf Extract, Portulaca Oleracea Extract, Melaleuca Alternifolia (Tea Tree) Extract, Nymphaea Alba Flower Extract, LavandulaAngustifolia (Lavender) Extract, CI 77492, Polyglyceryl-6 Polyricinoleate, Hydrogen Dimethicone, Polymethyl Methacrylate, CI 77491, Lauryl PEG-9 polydimethylsiloxyethyl dimethicone, Aluminium Hydroxide, Stearic Acid, Ultramarines, CI 77499, Butylene Glycol, Adenosine, Triethoxycaprylylsilane, Triethoxylsilylethyl PolydimethylsiloxyethylHexyl Dimethicone, Caprylyl Glycol, Disodium EDTA, Parfum

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:

For external use only Do not use on damaged broken skin Do not store at any high or low temperature or sunlight. Product uses high pressure gas flammable. Shake well before use Do not spray over 3 second on same place, face, must use on hand and then spread it on face If possible spray the product from 20cm or farther from body Do not inhale spray gas When using this product

Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use. Before dispose gas must be removed. Do not use near fire, heating device such as heater

Keep Out of Reach of Children

DESCRIPTION

Uses: Helps prevent sunburn

Directions 1. Turn the top of the container to “ON” 2. Shake the container up and down before use 3. And then pump 4-5 times 4. Open the cap and lightly apply on skin with the puff in a tapping motion (If the puff is too cold, wait for 5 seconds, and then evenly spread in a stroking motion) 5. After use, put the puff back in the container, close the cap and then turn the top of the container to “OFF” (Do not spray when closed)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR LEE UV ICE SHIELD 
titanium dioxide, octinoxate, zinc oxide, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71367-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	2.85 g  in 100 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	2.14 g  in 100 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1.61 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	1.43 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Butane (UNII: 6LV4FOR43R)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71367-010-02	1 in 1 CARTON	04/01/2017
1	NDC: 71367-010-01	100 mL in 1 BOTTLE; 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	04/01/2017

Labeler - DRLEECOSMETIC (694803063)

Registrant - DRLEECOSMETIC (694803063)

Establishment
Name	Address	ID/FEI	Business Operations
DRLEECOSMETIC		694803063	relabel(71367-010)

Establishment
Name	Address	ID/FEI	Business Operations
Seoul cosmetics co.,ltd		688397660	manufacture(71367-010)