Label: AHAVA ACTIVE DEADSEA MINERALS AGE CONTROL EVEN TONE MOISTURIZER BROAD SPECTRUM SPF20- avobenzone, octisalate, homosalate, 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 November 15, 2012

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Butyl Methoxydibenzoylmethane [3%]
    Ethylhexyl Salicylate [5%]
    Homosalate [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 to clean face 15 minutes before sun exposure
    • apply daily for a clearer, brighter complexion
    • 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 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

    Aloe Barbadensis Leaf Juice, Aminomethyl Propanediol, Aqua (Mineral Spring Water), Aqua (Water), Ascorbic Acid, Ascorbyl Glucoside, Benzotriazolyl Dodecyl p-Cresol, Butylene Glycol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Citric Acid, Citrus Reticulata (Tangerine) Peel Extract, Commiphora Abyssinica Resin Extract, Cucumis Sativus (Cucumber) Fruit Extract, Dimethicone, Disodium EDTA, Disodium Lauriminodipropionate Tocopheryl Phospates, Dunaliella Salina Extract, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Olive Oil Cetyl Esters, Hydrogenated Palm Glycerides, Hydrogenated Polydecene, Hydroxyapatite, Maris Aqua (Dead Sea Water), Melissa Officinalis Leaf Extract, Methylpropanediol, Myricetin, Octyldodecyl Neopentanoate, Oenothera Biennis (Evening Primrose) Oil, Opuntia Ficus- Indica Fruit Extract, Helianthus Annuus (Sunflower) Sprout Extract, Parfum (Fragrance), PEG-100 Stearate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocin, Pseudoalteromonas Ferment Extract, Pentylene Glycol, Pentylene Glycol, Phenoxyethanol, Phoenix Dactylifera (Date) Seed Extract, Polyglycerine-3, Polyglyceryl-3 polyricinoleate, Porphyra Umbilicalis Extract, Potassium Cetyl Phosphate, Propylene Glycol, Salicylic Acid, Scutellaria Baicalensis Extract, Sodium Citrate, Sodium Lactate, Stearyl Alcohol, Styrene/Acrylates Copolymer, Tocopheryl (Vitamin E) Acetate, Tris (Tetramethyl Hydroxypiperidinol) Citrate, Undecylcrylene Dimethicone, Xanthan Gum, Zinc PCA, Zizyphus Jujuba Fruit Extract.

  • 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 - 50 ml Jar Carton

    AHAVA

    ACTIVE DEADSEA MINERALS

    TIME TO SMOOTH

    AGE CONTROL EVEN TONE MOISTURIZER

    BROAD SPECTRUM SPF20

    50 ml e 1.7 fl.oz

    Principal Display Panel - 50 ml Jar Carton
  • INGREDIENTS AND APPEARANCE
    AHAVA ACTIVE DEADSEA MINERALS   AGE CONTROL EVEN TONE MOISTURIZER BROAD SPECTRUM SPF20
    avobenzone, octisalate, homosalate, and octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60289-247
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone1.5 g  in 50 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate2.5 g  in 50 mL
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate2.5 g  in 50 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene1.35 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Aminomethyl Propanediol (UNII: CZ7BU4QZJZ)  
    Water (UNII: 059QF0KO0R)  
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    Ascorbyl Glucoside (UNII: 2V52R0NHXW)  
    Benzotriazolyl Dodecyl p-Cresol (UNII: 298PX4M11X)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Calendula Officinalis Flower (UNII: P0M7O4Y7YD)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Tangerine Peel (UNII: JU3D414057)  
    Commiphora Madagascariensis Resin (UNII: WCM0X628RY)  
    Cucumber (UNII: YY7C30VXJT)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Disodium Lauriminodipropionate Tocopheryl Phosphates (UNII: 0K5Y9U1P6M)  
    Dunaliella Salina (UNII: F4O1DKI9A6)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Glycerin (UNII: PDC6A3C0OX)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    Hydrogenated Palm Glycerides (UNII: YCZ8EM144Q)  
    Tribasic Calcium Phosphate (UNII: 91D9GV0Z28)  
    Melissa Officinalis Leaf (UNII: 50D2ZE9219)  
    Methylpropanediol (UNII: N8F53B3R4R)  
    Myricetin (UNII: 76XC01FTOJ)  
    Octyldodecyl Neopentanoate (UNII: X8725R883T)  
    Evening Primrose Oil (UNII: 3Q9L08K71N)  
    Prickly Pear Fruit (UNII: 18V8PAQ629)  
    Helianthus Annuus Sprout (UNII: 4P26HG1S5W)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Phoenix Dactylifera Seed (UNII: 73NE6T0Q00)  
    Porphyra Umbilicalis (UNII: 14AN0J70WO)  
    Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Salicylic Acid (UNII: O414PZ4LPZ)  
    Scutellaria Baicalensis Root (UNII: 7J95K7ID2S)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Sodium Lactate (UNII: TU7HW0W0QT)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Tris(Tetramethylhydroxypiperidinol) Citrate (UNII: 7NW772I64Y)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Zinc Pidolate (UNII: C32PQ86DH4)  
    Jujube Fruit (UNII: G55HNL2C70)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60289-247-241 in 1 CARTON
    150 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35202/01/2013
    Labeler - AHAVA Dead Sea Laboratories Ltd (600056907)