DR YOUNG PROTECT PREVENT TRIPLE ACTION BB- titanium dioxide, octinoxate cream 
Tdc, Co. Ltd

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 8.0%, Ethylhexyl Methoxycinnamate 7.5%

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

Purpose: Sunscreen

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

Uses: - Ultralight, Multifunctional beauty cream to protect, perfect, tint, and moisturize skin - Features SPF 33 PA+++ sun protection

Directions: Apply moderate amount on entire face after basic skin care.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

DR YOUNG PROTECT PREVENT TRIPLE ACTION BB 
titanium dioxide, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43948-1330
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide2.40 g  in 30 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate2.25 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43948-1330-21 in 1 CARTON10/01/2017
1NDC:43948-1330-130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2017
Labeler - Tdc, Co. Ltd (687479378)
Registrant - Tdc, Co. Ltd (687479378)
Establishment
NameAddressID/FEIBusiness Operations
NEW & NEW CO.,LTD.557821160manufacture(43948-1330)

Revised: 11/2017
Document Id: a443b0a1-b275-4fb8-bb24-16b4b5e98095
Set id: dc1979a5-f36a-4a8f-a2e5-7d3443eb2d6c
Version: 1
Effective Time: 20171114
 
Tdc, Co. Ltd