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

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: 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

Image of carton

DR LEE UV ICE SHIELD 
titanium dioxide, octinoxate, zinc oxide, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71367-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide2.85 g  in 100 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate2.14 g  in 100 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.61 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate1.43 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Butane (UNII: 6LV4FOR43R)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71367-010-021 in 1 CARTON04/01/2017
1NDC:71367-010-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/01/2017
Labeler - DRLEECOSMETIC (694803063)
Registrant - DRLEECOSMETIC (694803063)
Establishment
NameAddressID/FEIBusiness Operations
DRLEECOSMETIC694803063relabel(71367-010)
Establishment
NameAddressID/FEIBusiness Operations
Seoul cosmetics co.,ltd688397660manufacture(71367-010)

Revised: 4/2017
Document Id: 6725b42b-e620-442f-b2cc-a1dd6e4b2eb6
Set id: 61da0382-e6a8-4d1f-b6fa-1245eb211e3a
Version: 1
Effective Time: 20170411
 
DRLEECOSMETIC