DR YOUNG PROTECT PREVENT 2P PEARL BRIGHTENING BALM- titanium dioxide, octinoxate, zinc oxide 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 8.90%, Ethylhexyl Methoxycinnamate 6.50%, Zinc Oxide 0.90%

INACTIVE INGREDIENT

Inactive ingredients: Water, Cyclopentasiloxane, Cyclohexasiloxane, Glycerin, Dipropylene Glycol, Hexyl Laurate, Butylene Glycol Dicaprylate/Dicaprate, Cetyl PEG/PPG-10/1 Dimethicone, Bentonite, Chrysanthellum Indicum Extract, Magnesium Sulfate, Pearl Powder, Magnolia Liliflora Flower Extract, Lilium Candidum Flower Extract, Convallaria Majalis Bulb/Root Extract, Butyrospermum Parkii (Shea) Butter, Magnolia Kobus Bark Extract, Thujopsis Dolabrata Branch Extract, Camellia Sinensis Leaf Extract, Citrus Grandis (Grapefruit) Fruit Extract, Centella Asiatica Extract, Althaea Rosea Flower Extract, Aloe Barbadensis Leaf Extract, Silica, CI 77492, CI 77491, CI 77499, Ultramarines, Sorbitan Isostearate, Tocopheryl Acetate, Ascorbyl Glucoside, Allantoin, Ceramide 3, Disodium EDTA, Methylparaben, Propylparaben, Fragrance

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, dark toned beauty balm to protect, tint, and moisturize skin - Features SPF 35 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 2P PEARL BRIGHTENING BALM 
titanium dioxide, octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43948-1310
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide2.67 g  in 30 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate1.95 g  in 30 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.27 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43948-1310-21 in 1 CARTON10/01/2017
1NDC:43948-1310-130 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
Biocostec Co., Ltd.690407325manufacture(43948-1310)

Revised: 12/2018
Document Id: 462378ba-2a00-4af8-9951-5cb680a9cb4d
Set id: a1dad74b-38cd-4c77-9c45-8a6d540bcaa3
Version: 2
Effective Time: 20181205
 
Tdc, Co. Ltd