Label: DR.JUCRE REBIRTH WHITE SUN PROTECTION- octinoxate, homosalate, octisalate, avobenzone, ensulizole, octocrylene, bemotrizinol, niacinamide, adenosine cream

  • NDC Code(s): 83071-060-01, 83071-060-02
  • Packager: NATURECELL CO., LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 8, 2022

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

  • ACTIVE INGREDIENTS

    Ethylhexyl Methoxycinnamate 7.30%
    Homosalate 6.00%
    Ethylhexyl Salicylate 4.50%
    Butyl Methoxydibenzoylmethane 4.00%
    Phenylbenzimidazole Sulfonic Acid 3.50%
    Octocrylene 2.00%
    Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine 1.50%
    Niacinamide 2.0%
    Adenosine 0.04%

  • INACTIVE INGREDIENTS

    Water, Butylene Glycol, Dimethicone, Dipropylene Glycol, Hydrogenated Poly(C6-14 Olefin), Neopentyl Glycol Diheptanoate, Cyclopentasiloxane, Methyl Methacrylate Crosspolymer, Aminomethyl Propanol, Cyclohexasiloxane, Caprylyl Methicone, Human Adipose Derived Stem Cell Conditioned Media, Potassium Cetyl Phosphate, Triceteareth-4 Phosphate, Glycol Stearate, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Silica, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-2 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Glyceryl Caprylate, Santalum Album (Sandalwood) Oil, Caprylyl Glycol, Xanthan Gum, Polysorbate 60, Sorbitan Isostearate, Disodium EDTA, Hydroxypropyl Cyclodextrin, Plankton Extract, Thioctic Acid, 1,2-Hexanediol, Tremella Fuciformis (Mushroom) Extract, Potassium Hydroxide

  • PURPOSE

    Sunscreen
    Sunscreen
    Sunscreen
    Sunscreen
    Sunscreen
    Sunscreen
    Sunscreen
    Skin Brightening
    Anti wrinkle

  • WARNINGS

    For external use only.
    Avoid contact with eyes.
    Discontinue use if signs of irritation or rashes appear.
    Replace the cap after use.
    Refrain from using it on wounded areas.
    Keep out of reach of children.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

  • Uses

    ■ Helps prevent sun burn
    ■ Helps brighten skin tone
    ■ Helps improve wrinkle problem

  • Directions

    ■ Apply an appropriate amount evenly on the skin.
    ■ Apply liberally and uniformly to all exposed areas 15-20 minutes before sun exposure. Reapply often (every 2 hours) and after swimming, excessive perspiration and washing to ensure maximum sun protection.

  • Other Information

    ■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light.

  • Questions

    ■ www.ibiostar.com
    ■ Tel (424)227-9568

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    DR.JUCRE REBIRTH WHITE SUN PROTECTION 
    octinoxate, homosalate, octisalate, avobenzone, ensulizole, octocrylene, bemotrizinol, niacinamide, adenosine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83071-060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.30 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE6.00 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.50 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE4.00 g  in 100 mL
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE3.50 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.00 g  in 100 mL
    BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH) BEMOTRIZINOL1.50 g  in 100 mL
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE2.00 g  in 100 mL
    ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE0.04 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83071-060-021 in 1 CARTON10/01/2022
    1NDC:83071-060-0165 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/01/2022
    Labeler - NATURECELL CO., LTD. (689282572)
    Registrant - NATURECELL CO., LTD. (689282572)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(83071-060)