Label: AHAVA AGE PERFECTING BROAD SPECTRUM SPF15- avobenzone, octisalate, and octocrylene cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 June 20, 2013

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Avobenzone [3%]
    Octisalate [5%]
    Octocrylene [2.7%]

  • Purpose

    sunscreens

  • Uses

    • helps prevent sunburn
  • Warnings

    For External Use Only

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

    Stop use and consult a doctor if rash or irritation develops and lasts

    Do not use on damaged or broken skin

    Keep out of reach of children. If swallowed, get medical attention or contact a Poison Control Centre right away.

  • Directions

    • apply liberally and evenly 15 minutes before sun exposure
    • children under 6 months of age: Ask a doctor
    • Use a water-resistant sunscreen if swimming or sweating.
    • Reapply 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 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 10a.m.-2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses
  • Inactive ingredients

    Aqua (Mineral Spring Water), Glycerin, Isohexadecane, Dimethicone, Butyloctyl Salicylate, Glyceryl Stearate, C12-15 Alkyl Benzoate, Peg-40 Stearate, Octyldodecyl Neopentanoate, Sodium Lactate, Stearyl Alcohol, Hydrogenated Olive Oil Cetyl Esters, Sorbitan Tristearate, Ascorbyl Glucoside, Maris Aqua (Dead Sea Water), Phenoxyethanol, Cetearyl Alcohol, Aloe Barbadensis Leaf Juice, Aminomethyl Propanediol, Butylene Glycol, Zizyphus Jujuba Fruit Extract, Salicylic Acid, Parfum (Fragrance), Niacinamide, Xanthan Gum, Dunaliella Salina Extract, Hydrogenated Polydecene, Caprylyl Glycol, Phoenix Dactylifera (DATE) Fruit Extract, Chlorphenesin, Dictyopteris Membranacea Extract, Sodium Citrate, Disodium EDTA, Helianthus Annuus (Sunflower) Seed Oil, Ascorbic Acid, Melissa Officinalis Leaf Extract, Polyglyceryl-3 polyricinoleate, Methylpropanediol, Citrus Reticulata (Tangerine) Peel Extract, Polyglycerine-3, Pentylene Glycol, Myricetin, Scutellaria Baicalensis Extract, Porphyra Umbilicalis Extract, Opuntia Ficus-Indica Fruit Extract, Helianthus Annuus (Sunflower) Sprout Extract, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocin, Pseudoalteromonas Ferment Extract, Commiphora Abyssinica Resin Extract, Citric Acid.

  • Other information

    • Protect the product in this container from excessive heat and direct sun
  • Questions or comments

    Call toll free 1-800-366-7254

  • SPL UNCLASSIFIED SECTION

    Dist: AHAVA N.A. LLC, NY, NY, 10016

  • PRINCIPAL DISPLAY PANEL - 75 mL Tube Carton

    AHAVA
    ACTIVE DEADSEA MINERALS

    TIME TO SMOOTH
    AGE PERFECTING HAND CREAM
    BROAD SPECTRUM SPF15
    dark spot correction

    75 ml e 2.5 fl.oz

    Principal Display Panel - 75 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    AHAVA AGE PERFECTING   BROAD SPECTRUM SPF15
    avobenzone, octisalate, and octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60289-280
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone2.25 g  in 75 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate3.75 g  in 75 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene2.05 g  in 75 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isohexadecane (UNII: 918X1OUF1E)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Peg-40 Stearate (UNII: ECU18C66Q7)  
    Octyldodecyl Neopentanoate (UNII: X8725R883T)  
    Sodium Lactate (UNII: TU7HW0W0QT)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Sorbitan Tristearate (UNII: 6LUM696811)  
    Ascorbyl Glucoside (UNII: 2V52R0NHXW)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Aminomethyl Propanediol (UNII: CZ7BU4QZJZ)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Jujube Fruit (UNII: G55HNL2C70)  
    Salicylic Acid (UNII: O414PZ4LPZ)  
    Niacinamide (UNII: 25X51I8RD4)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Dunaliella Salina (UNII: F4O1DKI9A6)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Date (UNII: H3O7QI5HY7)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Dictyopteris Polypodioides (UNII: 83H6O5GR42)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    Melissa Officinalis Leaf (UNII: 50D2ZE9219)  
    Polyglycerin-3 (UNII: 4A0NCJ6RD6)  
    Methylpropanediol (UNII: N8F53B3R4R)  
    Tangerine Peel (UNII: JU3D414057)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Myricetin (UNII: 76XC01FTOJ)  
    Scutellaria Baicalensis Root (UNII: 7J95K7ID2S)  
    Porphyra Umbilicalis (UNII: 14AN0J70WO)  
    Prickly Pear Fruit (UNII: 18V8PAQ629)  
    Helianthus Annuus Sprout (UNII: 4P26HG1S5W)  
    Commiphora Madagascariensis Resin (UNII: WCM0X628RY)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60289-280-261 in 1 CARTON
    175 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/15/2013
    Labeler - AHAVA Dead Sea Laboratories Ltd (600056907)