Label: ERYFOTONA ACTINICA ULTRALIGHT EMULSION- sunscreen emulsion

  • NDC Code(s): 69494-302-10, 69494-302-11, 69494-302-12, 69494-302-13, view more
    69494-302-14, 69494-302-30
  • Packager: ISDIN Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 19, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Zinc Oxide 11%

  • 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
  • Warning

    • 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 doctor if rash 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
    • During 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 the risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with 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.
  • Other information

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

    Water, Diethylhexyl Carbonate, Dibutyl Adipate, Cyclopentasiloxane, Dicaprylyl Carbonate, Alcohol Denat., Cyclohexasiloxane, Butylene Glycol, PEG-30 Dipolyhydroxystearate, Nylon-12, PEG-10 Dimethicone, Dimethicone, Sodium Chloride, Phenoxyethanol, Disteardimonium Hectorite, Triethoxycaprylylsilane, Tocopheryl Acetate, Glyceryl Stearate, Fragrance, Bisabolol, Disodium EDTA, Ethylhexylglycerin, Panthenol, PEG-8, Tocopherol, Lecithin, Plankton Extract, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid.

  • Questions or comments?

    Call (862) 242-8129
    Monday – Friday
    (9 a.m. to 5 p.m. EST)
    or visit www.isdin/us
    USA Patent Pending

  • PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

    ISDIN
    PHOTO

    Eryfotona
    Actinica®

    Ultralight Emulsion

    BROAD SPECTRUM SPF 50+

    Designed for
    Actinic Damage

    Sunscreen with
    DNA Repairsomes™
    and antioxidants.

    Water resistant
    (40 minutes)

    100% MINERAL
    SUNSCREEN

    3.4 FL OZ (100 mL)

    Principal Display Panel - 100 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ERYFOTONA ACTINICA ULTRALIGHT EMULSION 
    sunscreen emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69494-302
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE11 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    WATER (UNII: 059QF0KO0R)  
    DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)  
    Dibutyl Adipate (UNII: F4K100DXP3)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Dicaprylyl Carbonate (UNII: 609A3V1SUA)  
    Alcohol (UNII: 3K9958V90M)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
    Nylon-12 (UNII: 446U8J075B)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Disteardimonium Hectorite (UNII: X687XDK09L)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Panthenol (UNII: WV9CM0O67Z)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Tocopherol (UNII: R0ZB2556P8)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ANACYSTIS NIDULANS (UNII: UV4FTL6UAW)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69494-302-301 in 1 CARTON11/01/2019
    1100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:69494-302-101 in 1 CARTON11/01/201901/01/2021
    210 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:69494-302-121 in 1 CARTON11/01/2019
    32 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:69494-302-131 in 1 CARTON05/01/2023
    450 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:69494-302-1412 in 1 CARTON10/30/2023
    54 mL in 1 TUBE; Type 0: Not a Combination Product
    6NDC:69494-302-1112 in 1 CARTON12/18/2023
    62 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02008/17/2015
    Labeler - ISDIN Corp (079609155)
    Registrant - ISDIN Corp (079609155)
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