Label: FITGLOW VITA SHIELD HYALURONIC PRIMER SPF-30- zinc oxide cream

  • NDC Code(s): 72975-277-00, 72975-277-01
  • Packager: FITGLOW BEAUTY LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 11, 2023

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

  • DRUG FACTS

  • ACTIVE INGREDIENT(S)

    Zinc Oxide 14%

    PURPOSE

    Sunscreen

  • USE(S)

    • Helps prevent sunburn.
    • Higher SPF gives more sunburn protection.
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • WARNINGS

    For external use only

    Do not use

    • on damaged or broken skin.

    When using this product

    • keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if 

    • rash or irritation develops and lasts. 

    Keep out of reach of children. 

    If swallowed, get medical help or contact a Poison Control Center right away. 

    If pregnant or breast-feeding, 

    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 at least every 2 hours.
    • Use a water-resistant sunscreen if swimming or sweating.
    • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: Sun Protection Measures.
    • Limit time in the sun, especially from 10 a.m.-2 p.m.
    • Wear long-sleeved shirts, pants, hats and sunglasses.
  • Other Information:

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

    *Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Astaxanthin, Benzyl Alcohol, Betula Alba (Birch) Extract, Butyrospermum Parkii (Shea) Butter,C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Citric Acid, Daucus Carota Sativa (Carrot) Extract, Decyl Glucoside, Dehydroacetic Acid, Dodecane, Glycerin, Glyceryl Stearate, Glyceryl Stearate Citrate, Helianthus Annuus (Sunflower) Oil, Hyaluronic Acid, Lecithin, Mangifera Indica (Mango) Butter, Prunus Domestica (Plum) Fruit Extract, Punica Granatum (Pomegranate) Extract, Rubus Chamaemorus (Cloudberry) Oil, Sodium Polyacrylate, Stearic Acid, Tocopherol (Vitamin E), Tridecyl Salicylate, Propanediol.

    *Indicates certified organic ingredient.

  • QUESTIONS?

    Distributed by Fitglow Beauty LLC, 700 NE 13 Street, Ft. Lauderdale Florida, 33304 www.fitglowbeauty.com

  • Package Labeling: 45ml

    Label0

  • Package Labeling: 5ml

    Label02

  • INGREDIENTS AND APPEARANCE
    FITGLOW VITA SHIELD HYALURONIC PRIMER SPF-30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72975-277
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION140 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ASTAXANTHIN (UNII: 8XPW32PR7I)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CARROT (UNII: L56Z1JK48B)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    DODECANE (UNII: 11A386X1QH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    MANGO (UNII: I629I3NR86)  
    PLUM (UNII: 67M3EQ6BE1)  
    PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72975-277-001 in 1 BOX02/21/2022
    145 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:72975-277-015 mL in 1 PACKET; Type 0: Not a Combination Product03/23/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/21/2022
    Labeler - FITGLOW BEAUTY LLC (100394778)