Label: DO GOOD HYDRA HEALING TENSION PACT NATURAL BEIGE- octinoxate, titanium dioxide, octisalate powder

  • 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 March 13, 2018

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

  • ACTIVE INGREDIENT

    Active ingredients: Ethylhexyl Methoxycinnamate 7.00%, Titanium Dioxide 5.47%, Ethylhexyl Salicylate 3.00%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water, Cyclopentasiloxane, Butylene Glycol, Glycerin, Squalane, Cyclohexasiloxane, Butylene Glycol Dicaprylate/Dicaprate, Dicaprylyl Carbonate, Dimethicone, Niacinamide, Pentylene Glycol, Methyl Methacrylate Crosspolymer, Triceteareth-4 Phosphate, Glycol Stearate, Iron Oxides (CI 77492), Phenoxyethanol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, PEG-2 Stearate, Polysorbate 60, Potassium Cetyl Phosphate, PEG-10 Dimethicone, Carbomer, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Aluminum Hydroxide, Iron Oxides (CI 77491), Tromethamine, Triethoxycaprylylsilane, Fragrance(Parfum), Ethylhexylglycerin, Iron Oxides (CI 77499), Polysorbate 80, Adenosine, Disodium EDTA, Sorbitan Oleate, Madecassoside, Asiaticoside, Asiatic Acid, Madecassic Acid, Centella Asiatica Leaf Extract

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings:

    For external use only.

    Avoid contact with eyes.

    Discontinue use if signs of irritation or rashes appear.

    Replace the cap after use.

    Keep out of reach of children

  • DESCRIPTION

    Uses:

    Helps prevent sunburn.

    If used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging by the sun.

    Directions:

    Apply liberally 15 minutes before sun exposure

    Reapply at least every 2 hours

    Use a water resistant sunscreen if swimming or sweating

    Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging.

    To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

    Limit time in the sun, especially from 10 a.m. – 2 p.m.

    Wear long-sleeved shirts, pants, hats and sunglasses

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    DO GOOD HYDRA HEALING TENSION PACT NATURAL BEIGE 
    octinoxate, titanium dioxide, octisalate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72058-090
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate1.08 g  in 15.5 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.84 g  in 15.5 g
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.46 g  in 15.5 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72058-090-021 in 1 CARTON02/01/2018
    1NDC:72058-090-0115.5 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2018
    Labeler - WOOREE Colourone Co.,Ltd (694492496)
    Registrant - WOOREE Colourone Co.,Ltd (694492496)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(72058-090)