Label: HYDRADAY- octocrylene and avobenzone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 21, 2013

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  • ACTIVE INGREDIENT

    Active Ingredients                                                               Purpose

    Octocrylene 5% ................................................................. Sunscreen

    Avobenzone (Butyl Methoxydibenzoyl Methane) 3% ......... Sunscreen

  • PURPOSE

    Desheli

    Diamond Treasure

    Hydraday Face Moisturizer - Sunscreen SPF15

    Based on Fytotigh™

    Manufactured exclusively for Desheli by E.L Erman, Cosmetic Manufacturing, Ltd., 3 Haplada Street, P.O.B 12189 Ashdod, ISRAEL

    Distributed: (US) PF Invest Company, Las Vegas, NV, 89101; 1-800-DeSheli (EU) PF Invest SIA, Reg.nr.40103686040, LV-1004, RIGA, LATVIA

    Made in Israel

    Other Information

    Protect this product from excessive heat and direct sun

    Questions or comments?

    Call toll free 1-800-DeSheli M-F 8 a.m. - 5 p.m. (PST) desheli.com

    50 ml e 1,69 fl.oz.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Uses

    Moisturizer cream provides deep hydration with UV protection for a beautiful, youth-inspired complexion. Nourishing antioxidants fight with free radicals, helps to protect the skin all day long against environmental aggressors.

  • WARNINGS

    Warnings

    Skin cancer/skin aging alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunbutn not skin cancer or early skin aging

    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 occurs.

  • DOSAGE & ADMINISTRATION

    Uses

    Moisturizer cream provides deep hydration with UV protection for a beautiful, youth-inspired complexion. Nourishing antioxidants fight with free radicals, helps to protect the skin all day long against environmental aggressors.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Cetearyl alcohol, alpha hydroxy acid (fruit base), glycerin, sesame (sesamum indicum) seed oil, beeswax (cera alba), cetyl alcohol, aloe barbadensis leaf juice, FYTOTIGH™ (PhytoCell Tec™Argan (argania spinosa sprout cell extract & isomalt & lecithin & sodium benzoate & aqua/water), PhytoCell Tec™Solar Vitis (Grape (vitis vinifera) fruit cell extract & isomalt & lecithin & sodium benzoate & aqua/water), PhytoCell Tec™Malus Domestica (apple (pyrus malus) pectin extract & xanthan gum & glycerin & lecithin & phenoxyethanol & aqua/water & propanediol & hexapeptide-42)), phenoxyethanol, stearic acid, maris aqua (Dead Sea water), borage (borago officinalis) seed oil, gluconolactone, dog rose (rosa canina) fruit oil, dimethicone, shea butter (butyrospermum parkii), calendula officinalis flower oil, fragrance (parfum), sodium benzoate, chamomile (anthemis nobilis) flower extract, jojoba (simmondsia chinensis) seed oil, triethylene glycol, water (aqua) & glycerin & xanthan gum & diamond powder, evening primrose (oenothera biennis) oil, tocopheryl acetate

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    HYDRADAY 
    octocrylene and avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61220-001(NDC:43638-001)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.5 mg  in 50 mg
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 mg  in 50 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SESAME OIL (UNII: QX10HYY4QV)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARGANIA SPINOSA WHOLE (UNII: 83K6O4FR76)  
    ISOMALT (UNII: S870P55O2W)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MALUS DOMESTICA WHOLE (UNII: 04W636S1V3)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TRIETHYLENE GLYCOL (UNII: 3P5SU53360)  
    DIAMOND (UNII: 6GRV67N0U2)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61220-001-0150 mg in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/20/2013
    Labeler - PF Invest Company (079180054)
    Establishment
    NameAddressID/FEIBusiness Operations
    PF Invest Company079180054relabel(61220-001)
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