Label: DR YOUNG PROTECT PREVENT TRIPLE ACTION BB- titanium dioxide, octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 43948-1330-1, 43948-1330-2 - Packager: Tdc, 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 November 14, 2017
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: Water, Phenyl Trimethicone, Propylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Arbutin, Cyclopentasiloxane, Hexyl Laurate, Cyclohexasiloxane, Methyl Methacrylate Crosspolymer, Iron Oxides (CI 77492), Glycerin, Magnesium Sulfate, Sorbitan Sesquioleate, Zinc stearate, Caprylyl Methicone, Dimethicone, Microcrystalline Wax, Ozokerite, Isostearyl Isostearate, Polyglyceryl-4 Isostearate, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Quaternium-18 Bentonite, Dimethicone/Vinyl Dimethicone Crosspolymer, Phenoxyethanol, Triethoxycaprylylsilane, Sodium Chloride, Silica Dimethyl Silylate, PEG/PPG-19/19 Dimethicone, Phellinus Linteus Extract, Cyclotetrasiloxane, Caprylyl Glycol, Butylene Glycol, Portulaca Oleracea Extract, Allantoin, Hydroxyethylcellulose, Ultramarines(CI 77007), Centella Asiatica Extract, Piper Methysticum Leaf/Root/Stem Extract, Adenosine, Caprylhydroxamic Acid, Petrolatum, Tocopheryl Acetate, Mica, Polysilicone-11, Aloe Barbadensis Leaf Juice, Lilium Candidum Bulb Extract, Iris Versicolor Extract, Freesia Alba Flower Extract, Narcissus Pseudo-Narcissus (Daffodil) Flower Extract, Rosa Damascena Flower Water, Leontopodium Alpinum Extract, Nelumbo Nucifera Flower Extract, Jasminum Officinale (Jasmine) Flower/Leaf Extract
- PURPOSE
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WARNINGS
Warning: 1) For external use only. 2) Consult a dermatologist if the first sign occurs like red spot, swelling, itching, or any allergic reactions. 3) Avoid direct contact with eyes. 4) If contact occurs, flush thoroughly with water. 5) If swallowed, get medical help or contact a Poison Control Center right away. 6) Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
Storage and cautions for handling: 1) Keep out of reach of children. 2) Keep away from high or low temperature and direct sunlight.
- DESCRIPTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DR YOUNG PROTECT PREVENT TRIPLE ACTION BB
titanium dioxide, octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43948-1330 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 2.40 g in 30 mL Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate 2.25 g in 30 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Phenyl Trimethicone (UNII: DR0K5NOJ4R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43948-1330-2 1 in 1 CARTON 10/01/2017 1 NDC:43948-1330-1 30 mL in 1 TUBE; 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 10/01/2017 Labeler - Tdc, Co. Ltd (687479378) Registrant - Tdc, Co. Ltd (687479378) Establishment Name Address ID/FEI Business Operations NEW & NEW CO.,LTD. 557821160 manufacture(43948-1330)
