Label: MINI BERRY LIP BALM BLUEBERRY- octinoxate, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 59078-038-01 - Packager: TONYMOLY CO., LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 March 4, 2015
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients: Polyglyceryl-2 Triisostearate, Petrolatum, Diisostearyl Malate, Bis-Diglyceryl Polyacyladipate-2, Polybutene, Benzophenone-3, Hydroxystearic Acid, Microcrystalline Wax, Silica Dimethyl Silylate, VP/Hexadecene Copolymer, Mica (CI 77019), Sorbitan Isostearate, Red 28 Lake (CI 45410), Fragrance(Parfum), Butylparaben, Tocopheryl Acetate, Methicone, Polyglyceryl-2 Diisostearate, Red 6 (CI 15850), Yellow 5 Lake (CI 19140), Vaccinium Angustifolium (Blueberry) Fruit Extract, Water, Butylene Glycol, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Fragaria Chiloensis (Strawberry) Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract, Rubus Fruticosus (Blackberry) Fruit Extract, Phenoxyethanol, Methylparaben, Ethylparaben, Isobutylparaben, Propylparaben
- PURPOSE
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WARNINGS
Warnings: 1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MINI BERRY LIP BALM BLUEBERRY
octinoxate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59078-038 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.36 g in 7.2 g Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 0.01 g in 7.2 g Inactive Ingredients Ingredient Name Strength Petrolatum (UNII: 4T6H12BN9U) Diisostearyl Malate (UNII: QBS8A3XZGQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59078-038-01 7.2 g in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/01/2013 Labeler - TONYMOLY CO., LTD. (688216798) Registrant - TONYMOLY CO., LTD. (688216798) Establishment Name Address ID/FEI Business Operations TONYMOLY CO., LTD. 688216798 repack(59078-038) Establishment Name Address ID/FEI Business Operations COSMAX INC. 689019313 manufacture(59078-038)
