Label: CORALSAFE BROAD SPECTRUM SPF30- titanium dioxide, zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 10, 2023

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

View All Sections
  • DRUG FACTS

  • Active Ingredients

    Titanium Dioxide (6.0%)

    Zinc Oxide (6.0%)

    Purpose

    Sunscreen

  • 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 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 occurs.

    Keep out of reach of children.

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

  • Directions:

    • Apply liberally 15 minutes before sun exposure • Reapply • After 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • 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 of 15 or higher and other sun protection measures including: Sun Protection Measures:

    • Limiting time in the sun, especially from 10 am - 2 pm. • Wearing long-sleeve shirts, pants, hats and sunglasses • Children under 6 months: Ask a doctor

  • Inactive Ingredients:

    Aloe Barbadensis (Aloe Vera) Juice, Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Cocos Nucifera (Coconut) Oil, Dehydroxanthan Gum, Gluconolactone, Glycerin, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Oil, Lecithin, Mangifera Indica (Mango) Butter, Sodium Benzoate, Sodium Laurylglucosides Hydroxypropylsulfonate, Styrene/Acrylates Copolymer, Tocopheryl (Vitamin-E), Xanthan Gum.

  • Other Information:

    Protect this product from excessive heat and direct sun.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    CORALSAFE BROAD SPECTRUM SPF30 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71221-333
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE60 mg  in 1 L
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION60 mg  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    MANGO (UNII: I629I3NR86)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71221-333-001 in 1 CARTON06/01/2018
    13.78 L in 1 JUG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/01/2018
    Labeler - Elements Brands (006166707)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!