FACE OASIS HYDRATING FACE OASIS HYDRATING SPF 30 (AVOBENZONE,HOMOSALATE,OCTISALATE,OXYBENZONE) LOTION [H2O PLUS]

FACE OASIS HYDRATING FACE OASIS HYDRATING SPF 30 (AVOBENZONE,HOMOSALATE,OCTISALATE,OXYBENZONE) LOTION [H2O PLUS]
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NDC 65903-270-01
Set ID 2bfe13c3-ddf0-4f05-ad40-751b1b808bf3
Category HUMAN OTC DRUG LABEL
Packager H2O PLUS
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT


    Avobenzone 3.0%
    Homosalate 8.0%
    Octisalate 4.0%
    Oxybenzone 5.0%

    Sunscreen
    Sunscreen
    Sunscreen
    Sunscreen

    Helps prevent sunburn
    If used as directed with other sun protection measures
    (see directions) decreases the risk of skin cancers and early skin aging

    For external use only • Do not use on damaged or broken skin
    • Stop use and ask a doctor if rash occurs

    Keep out of eyes, Rinse with water to remove. Keep out of reach of children.
    If swallowed, get medical help or contact a Poison Control Center right away

    • For Sunscreen use
    • Apply liberally 15 minutes before sun exposure
    • Use water resistance sunscreen if swimming or sweating
    • Reapply at least every 2 hours
    • Children under 6 months: Ask a doctor

    Protect the product in this container from excessive heat
    and direct sun

    Aqua/Water/Eau, Ascorbyl Tetraisopalmitate, Blue 1 (CI 42090), Butylene
    Glycol, C12-15 Alkyl Benzoate, C12-20 Alkyl Glucoside, C14-22 Alcohols,
    Caprylic/Capric Triglyceride, Carbomer, Crithmum Maritimum Extract,
    Cyclopentasiloxane, Dimethicone, DNA, Ext. Violet 2 (CI 60730), Glycerin,
    Glyceryl Stearate, Leuconostoc/Radish Root Ferment Filtrate, Linalool,
    Magnesium Ascorbyl Phosphate, Methylisothiazolinone,
    Parfum/Fragrance, Phenoxyethanol, Phospholipids, Silica, Tocopherol,
    Triethanolamine, Trisiloxane, Ulva Lactuca Extract, Undaria Pinnatifida
    Extract, Xanthan Gum
  • PRINCIPAL DISPLAY PANEL

    Image of Carton Label fa270.jpgImage of Carton Label

  • INGREDIENTS AND APPEARANCE
    FACE OASIS HYDRATING   FACE OASIS HYDRATING SPF 30
    avobenzone,homosalate,octisalate,oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65903-270
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3 mL  in 100 mL
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate8 mL  in 100 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate4 mL  in 100 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HERRING SPERM DNA (UNII: 51FI676N6F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRIETHANOLAMINE HYDROCHLORIDE (UNII: R297UJ9QDY)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    ULVA LACTUCA (UNII: PHR3P25W6Y)  
    UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65903-270-011 in 1 CARTON
    138 mL in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/01/2012
    Labeler - H2O PLUS (807722947)

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