Label: CORAL CARE SPF 30 SUNSCREEN- titanium dioxide 8.8% lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 19, 2024

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

  • ACTIVE INGREDIENT

    Titanium Dioxide 8.8%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    Helps prevent sunburn.

  • WARNINGS

    For external use only.

    Do not use on damaged or broken skin.

    Stop use and ask a doctor if rash occurs.

    When using this product keep out of eyes. Rinse with water to remove.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions: apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at lease every 2 hours. For children under 6 months of age: ask a doctor.

  • INACTIVE INGREDIENT

    Water/Aqua, Caprylic/Capric Triglyceride, Aloe Barbadensis (Aloe)* Leaf Juice, Cocoglycerides, Glycerin, Camellia Sinensis (Green Tea)* Leaf Extract, Ocimum Tenuiflorum (Tulsi)* Extract, Alaria Esculenta (Wakame Seaweed)* Extract, Olea Europaea (Olive)* Leaf Extract, Sorbitan Olivate, Cetyl Palmitate, Cetearyl Olivate, Methylcellulose, Cetearyl Alcohol, Polyhydroxystearic Acid, Acrylates Copolymer, Helianthus Annuus (Sunflower) Oil, Magnesium Aluminum Silicate, Stearic Acid, Tocopherol, Xanthan Gum, Alumina, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, Maris Aqua (Sea Water).

    *Organic Ingredients

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    CORAL CARE SPF 30 SUNSCREEN 
    titanium dioxide 8.8% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69555-032
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE8.8 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALUMINA (UNII: LMI26O6933)  
    COCOGLYCERIDES (UNII: ISE9I7DNUG)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALARIA ESCULENTA (UNII: EJ9JK8J58D)  
    SORBIC ACID (UNII: X045WJ989B)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    METHYLCELLULOSE (UNII: Z944H5SN0H)  
    HOLY BASIL LEAF (UNII: SCJ765569P)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69555-032-0275 mL in 1 TUBE; Type 0: Not a Combination Product11/19/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/19/2024
    Labeler - Stream2Sea (052920828)
    Registrant - Stream2Sea (052920828)
    Establishment
    NameAddressID/FEIBusiness Operations
    Stream2Sea052920828manufacture(69555-032)