Label: DAILY PREVENTION PROTECT AND REFRESH MIST SPF 40- avobenzone, octisalate and octocrylene spray

  • NDC Code(s): 62742-4257-1, 62742-4257-2
  • Packager: Allure Labs
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated March 21, 2024

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  • ACTIVE INGREDIENT

    Active ingredients

    Avobenzone 2.9%

    Octisalate 4.9%

    Octocrylene 9.5%

  • PURPOSE

    Purpose: Sunscreen

  • INDICATIONS & USAGE

    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

    Warnings: Flammable. Keep away from fire or flame. • For external use only

  • DO NOT USE

    Do not use • on damaged or broken skin

  • WHEN USING

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

  • STOP USE

    Stop use and ask a doctor if • rash occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions • shake well before use • hold container 4 to 6 inches from the skin to apply • spray liberally and spread evenly by hand 15 minutes before sun exposure • avoid contact with eyes • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • children under 6 months of age: ask a doctor • Sun Protection Measures. 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 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-sleeved shirts, pants, hats and sunglasses

  • OTHER SAFETY INFORMATION

    Other information • protect the product in this container from excessive heat and direct sun.

  • INACTIVE INGREDIENT

    Inactive ingredients: Alcohol, Diisooctyl Succinate, Butyloctyl Salicylate, Aqua/water/Eau, Ethylhexyl Methoxycrylene, VA/Butyl Maleate/ Isobornyl Acrylate Copolymer, Alcohol Denat., Acetyl Zingerone, Caprylie/Capric Triglyceride, Ethyl Ferulate, Polyester-8, Mauritia Flexuosa Fruit Oil, Limnanthes Alba Seed Oil, Glycerin, Brassica Campestris Seed Oil, Rubus Idaeus Seed Oil, T-Butyl Alcohol, Vanilla Planifolia Fruit Extract, Glycyrrhiza Glabra Root Extract, Polyglyceryl-3 Diisostearate, Opuntia Ficus-Indica Leaf Cell Extract, Camellia Sinensis Leaf Extract, Bisabolol, Phosphatidylcholine, Althaea Officinalis Root Extract, Oryza Sativa Bran Extract, Mannitol, Methylpropanediol, Ectoin, Caprylyl Glycol, Denatonium Benzoate, Stearic Acid, Palmitic Acid, Haematococcus Pluvialis Extract, Tetrahexyldecyl Ascorbate, Panthenol, Phenylpropanol, Sodium Benzoate, Potassium Sorbate.

  • PRINCIPAL DISPLAY PANEL

    DAILY PREVENTION_Protect and Refresh Mist_SPF40

  • INGREDIENTS AND APPEARANCE
    DAILY PREVENTION PROTECT AND REFRESH MIST SPF 40 
    avobenzone, octisalate and octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4257
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9.5 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.9 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.9 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    OPUNTIA FICUS-INDICA LEAF (UNII: 5VM709H93V)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    DIISOBUTYL SUCCINATE (UNII: 1241X4J800)  
    ISOBORNYL ACRYLATE (UNII: IX0PRH184P)  
    ACETYL ZINGERONE (UNII: V9D92S9YE5)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    ECTOINE (UNII: 7GXZ3858RY)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)  
    VANILLA BEAN (UNII: Q74T35078H)  
    RICE BRAN (UNII: R60QEP13IC)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    DIBUTYL MALEATE (UNII: 4X371TMK9K)  
    MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BRASSICA RAPA SUBSP. RAPA SEED (UNII: 728X944L6M)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    PHOSPHATIDYLCHOLINE TRANSLOCATOR ABCB4 (UNII: 9EI49ZU76O)  
    MANNITOL (UNII: 3OWL53L36A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4257-21 in 1 CARTON03/21/2024
    1NDC:62742-4257-1100 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/21/2024
    Labeler - Allure Labs (926831603)
    Registrant - Allure Labs (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs926831603manufacture(62742-4257)