Label: DR LEE UV ICE SHIELD- titanium dioxide, octinoxate, zinc oxide, octisalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71367-010-01, 71367-010-02 - Packager: DRLEECOSMETIC
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated April 11, 2017
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
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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
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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
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INGREDIENTS AND APPEARANCE
DR LEE UV ICE SHIELD
titanium dioxide, octinoxate, zinc oxide, octisalate creamProduct 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)
