Label: DR YOUNG PROTECT PREVENT 2P BLEMISH BASE- titanium dioxide, octinoxate, zinc oxide cream

  • 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 December 5, 2018

If you are a consumer or patient please visit this version.

  • 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 Morifolium Flower Extract, Magnesium Sulfate, Althaea Rosea Flower Extract, Aloe Barbadensis Leaf Extract, Butyrospermum Parkii (Shea) Butter, Centella Asiatica Extract, Silica, CI 77492, CI 77491, CI 77499, Sorbitan Isostearate, Tocopheryl Acetate, Allantoin, Ceramide 3, Methylparaben, Propylparaben, Disodium EDTA, 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, pink 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

  • INGREDIENTS AND APPEARANCE
    DR YOUNG PROTECT PREVENT 2P BLEMISH BASE 
    titanium dioxide, octinoxate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43948-1300
    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:43948-1300-21 in 1 CARTON10/01/2017
    1NDC:43948-1300-130 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(43948-1300)