Label: TONYMOLY KISS KISS LIP ESSENCE BALM- octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 59078-046-01 - 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 June 25, 2014
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients:
Polyglyceryl-2 Triisostearate, Polybutene, Diisostearyl Malate, Petrolatum, Pentaerythrityl Tetraethylhexanoate, Microcrystalline Wax, Benzophenone-3, Hydroxystearic Acid, Silica Dimethyl Silylate, Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Glyceryl Behenate, Polyglyceryl-6 Octastearate, Fragrance(Parfum), Butylparaben, Tocopheryl Acetate, Yellow 6 Lake (CI 15985), Water, Honey Extract - PURPOSE
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WARNINGS
Warning:
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 AND USAGE
- DOSAGE AND ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TONYMOLY KISS KISS LIP ESSENCE BALM
octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59078-046 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 Inactive Ingredients Ingredient Name Strength Petrolatum (UNII: 4T6H12BN9U) Silica Dimethyl Silylate (UNII: EU2PSP0G0W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59078-046-01 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 05/01/2014 Labeler - TONYMOLY CO., LTD. (688216798) Registrant - TONYMOLY CO., LTD. (688216798) Establishment Name Address ID/FEI Business Operations TONYMOLY CO., LTD. 688216798 manufacture(59078-046)