Label: SOLARA SUNCARE - FORTUNE TELLER SPF-30- zinc oxide lotion

  • NDC Code(s): 73054-120-01, 73054-120-11
  • Packager: SOLARA SUNCARE, INC.
  • 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 February 8, 2023

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  • ACTIVE INGREDIENTS

    Zinc Oxide 22.4%

  • 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 occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.

  • DIRECTIONS

    • shake or knead before each use
    • apply generously and evenly 15 minutes before sun exposure
    • reapply:
    • after 40 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use asunscreen 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-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor
  • INACTIVE INGREDIENTS

    Water (Aqua), Caprylic/Capric Triglyceride, Glycerin, C13-14 Alkane, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Butyrospermum Parkii (Shea) Butter, Coco-Caprylate, Propanediol, Cocos Nucifera (Coconut) Oil, Hydrogenated Castor Oil, Magnesium Sulfate, Helianthus Annuus (Sunflower) Seed Wax, Squalane, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Withania Somnifera (Ashwagandha) Root Extract, Perilla Frutescens (Mint) Leaf Extract, Punica Granatum Flower Extract, Avena Sativa (Oat) Kernel Extract, Gardenia Taitensis (Tahitian Gardenia) Flower Extract, Rubus Idaeus Leaf Extract, Potassium Sorbate, Terminalia Ferdinandiana Fruit Extract, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Cetyl Palmitate, Sorbitan Palmitate, Caprylyl Glycol, Phenylpropanol, Sorbitan Olivate, Isostearic Acid, Lecithin, Fructose

  • OTHER INFORMATION

    • Protect this product from excessive heat and direct sun.
  • QUESTIONS OR COMMENTS

    • 1-855-859-1600 (9am – 5pm ET)
  • PRINCIPAL DISPLAY PANEL

    unit carton

  • INGREDIENTS AND APPEARANCE
    SOLARA SUNCARE - FORTUNE TELLER  SPF-30
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73054-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    ENOXOLONE DIPOTASSIUM (UNII: ZJI2YIM6Z9)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    POTASSIUM HYDROLYZED JOJOBA ESTERS (UNII: CH428W5O62)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    PEA PROTEIN (UNII: 7Q50F46595)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)  
    SODIUM SUCCINATE HEXAHYDRATE (UNII: U16QOD6C4E)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SHEANUT (UNII: 84H6HBP32L)  
    APPLE (UNII: B423VGH5S9)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73054-120-111 in 1 BOX07/06/2019
    1NDC:73054-120-0190 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/06/2019
    Labeler - SOLARA SUNCARE, INC. (040998319)
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