Label: ALLIES OF SKIN SUNLESS TAN SPF 50 DAILY SELF TANNER- avobenzone, homosalate, octocrylene, octisalate liquid

  • NDC Code(s): 83852-543-00
  • Packager: ALLIES GROUP PTE. LTD.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 29, 2024

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

  • Drug Facts

  • Active Ingredients

    Avobenzone 3.00% 

    Homosalate 7.30%

    Octocrylene 7.50% 

    Octisalate 5.00%

    Purpose

    Sunscreen

  • Uses:

    • Helps prevent sunburn.
    • Higher SPF gives more sunburn protection.
    • 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 develops and lasts.

    Keep out of reach of children.

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

    If pregnant or breast-feeding,

    ask a health professional before use.

  • Directions:

    • Apply liberally 15 minutes before sun exposure and as needed.
    • Children under 6 months of age: ask a doctor.
    • Reapply:
    • after 80 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 a sunscreen with broad spectrum SPF 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 Information:

    • Protect the product in this container from excessive heat and direct sun.
    • May stain or damage some fabrics or surfaces.
  • Inactive Ingredients:

    Aloe Barbadensis Leaf Juice, Ascorbic Acid, Bisabolol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, C9-12 Alkane, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Centella Asiatica Extract, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Daucus Carota Sativa (Carrot) Seed Extract, Dihydroxyacetone, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Dodecane, Ethyl Vanillin, Ethylhexylglycerin, Glycerin, Glyceryl Stearate Citrate, Glyceryl Stearate SE, Glycyrrhiza Glabra (Licorice) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, Isododecane, Lactobacillus Ferment, Lycium Barbarum Fruit Extract, Magnesium Aluminum Silicate, Octyldodecyl Neopentanoate, Phenoxyethanol, Polysorbate 20, Potassium Cetyl Phosphate, Propanediol, Punica Granatum Fruit Extract, Sodium Hyaluronate, Sodium Metabisulfite, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Vaccinium Angustifolium (Blueberry) Fruit Extract, Vitis Vinifera (Grape) Seed Oil, Water (Aqua), Xanthan Gum

  • Package Labeling:

    Outer PackageInner Package

  • INGREDIENTS AND APPEARANCE
    ALLIES OF SKIN SUNLESS TAN SPF 50 DAILY SELF TANNER 
    avobenzone, homosalate, octocrylene, octisalate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83852-543
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE73 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    C9-12 ALKANE (UNII: 7J5R5W72QM)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DAUCUS CAROTA SUBSP. SATIVUS SEED (UNII: 9M6AAX381U)  
    DIHYDROXYACETONE (UNII: O10DDW6JOO)  
    DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)  
    DODECANE (UNII: 11A386X1QH)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ISODODECANE (UNII: A8289P68Y2)  
    LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LOWBUSH BLUEBERRY (UNII: G90PX41VP0)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83852-543-001 in 1 BOX10/14/2024
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/14/2024
    Labeler - ALLIES GROUP PTE. LTD. (595420087)