Label: GUIDANCE TO GLOW TRU SPF 35- zinc oxide cream

  • NDC Code(s): 84444-506-00
  • Packager: GUIDANCE TO GLOW SKIN CARE
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 25, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts

  • Active Ingredients

    Zinc Oxide 12%

    Purpose

    Sunscreen

  • Uses:

    • Helps Prevent Sunburn
    • Higher SPF gives more sunburn protection
    • Retains SPF after 80 minutes of swimming or sweating
    • If used as directed with other sun protection measures (see directions)

    Decreases the risk ok skin cancer and early skin aging caused by the sun

  • Warnings:

    For external use ONLY

    Do not use

    on damaged skin

    When using this product:

    keep out of eyes Rinse with water to remove

    Stop use and ask a doctor:

    Rash or irritation develops and lasts

    Keep out of reach of children.

    If swallowed,get medical help or contact a poison control center right way.

    If pregnant or breastfeeding,

    ask a health professional before use

  • Directions:

    • Apply liberally 15 minutes before sun exposure and as needed
    • Children under 6 months of age: ask a doctor
    • Reapply 
    • After 80 minutes of swimming or sweating
    • Immediately after towel drying
    • Sun Protection Measures.

    Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk. Regularly use sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including

    • Limit time in the sun especially from 10a.m - 2 p.m
    • Wear long-sleeve shirts, pants, hats, and sunglasses
  • Other information

    Protect the product in this container from excessive heat and direct sun.

    Water Resistant 80 minutes.

  • Inactive Ingredients:

    Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), a-Bisabalol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Caprylic/Capris Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Citric Acid, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Dodecane, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Hydrolyzed Oat Protein, Isododecane, C13-14 Isoparaffin, Laureth-7, Magnesium Aluminum Silicate, Malus Domestica (Apple) Extract Phenoxyethanol, Plankton Extract, Polyacrylamide, Polyhydroxystearic Acid, Polysorbate-20, Potassium Sorbate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Squalane, Tetrasodium Glutamate Diacetate, Tocopheryl Acetate (Vitamin E), Trimethylsiloxysilicate, Xanthan Gum, Zemea (Corn) Propanediol

  • Any Questions?

    818-863-6299

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    GUIDANCE TO GLOW TRU SPF 35 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84444-506
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION120 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CARROT (UNII: L56Z1JK48B)  
    DODECANE (UNII: 11A386X1QH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    ISODODECANE (UNII: A8289P68Y2)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    APPLE (UNII: B423VGH5S9)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    SQUALANE (UNII: GW89575KF9)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CORN (UNII: 0N8672707O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84444-506-001 in 1 BOX06/12/2024
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/12/2024
    Labeler - GUIDANCE TO GLOW SKIN CARE (035140244)