Label: ZO SKIN HEALTH OCLIPSE SUN SPF 50 BROAD SPECTRUM SUNSCREEN SPF 50 FOR FACE PLUS BODY WATER/PERSPIRATION RESISTANT (80 MINUTES)- avobenzone, homosalate, octisalate, and octocrylene aerosol, spray

  • 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 March 10, 2016

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Avobenzone 3%Sunscreen
    Homosalate 15%Sunscreen
    Octisalate 5%Sunscreen
    Octocrylene 10%Sunscreen
  • Uses

    • helps prevent sunburn
    • higher SPF gives more sunburn protection
    • retains SPF after 80 minutes of perspiring
    • 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

    Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120ºF.

    Keep out of reach of children.

    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

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

  • Directions

    • apply liberally 15 minutes before sun exposure
    • 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 this risk, regularly use a sunscreen with a Broad Spectrum SPF value 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.
    • you may report a serious adverse reaction to:
      1 Technology Dr. B123, Irvine, CA 92618
  • Inactive ingredients

    Water, Cetyl Dimethicone, Aluminum Starch Octenylsuccinate, SD Alcohol 40, C12-15 Alkyl Benzoate, Glycerin, Styrene/Acrylates Copolymer, Polyester-7, Neopentyl Glycol Diheptanoate, Steareth-100, Steareth-2, Mannan, Xanthan Gum, Polyester-8, Ethylhexylglycerin, Phenoxyethanol, Sodium PCA, Ethylhexyl Stearate, Argania Spinosa Kernel Oil, Beta-Glucan, Cyclopentasiloxane, Acrylates/Dimethicone Copolymer, Propylene Glycol, Trideceth-6, C10-30 Cholesterol/Lanosterol Esters, Caprylyl Glycol, Melanin, Panthenyl Triacetate, Ethyl Linoleate, Oleyl Alcohol, Tocopherol, Polymethyl Methacrylate, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Zanthoxylum Bungeanum Fruit Extract, Cedrus Atlantica Bark Extract, Portulaca Oleracea Extract, Disodium EDTA, Bisabolol.

  • SPL UNCLASSIFIED SECTION

    DIST BY
    ZO Skin Health, Inc.
    Irvine, CA 92618

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    ZO® SKIN HEALTH

    BY ZEIN OBAGI, MD

    NDC 42851-054-21

    OCLIPSE®
    SUN SPRAY SPF 50
    BROAD SPECTRUM SUNSCREEN
    SPF 50 FOR FACE + BODY
    WATER/PERSPIRATION RESISTANT
    (80 minutes)

    118 mL / 4 Fl. Oz.

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ZO SKIN HEALTH OCLIPSE SUN SPF 50 BROAD SPECTRUM SUNSCREEN SPF 50 FOR FACE PLUS BODY WATER/PERSPIRATION RESISTANT (80 MINUTES) 
    avobenzone, homosalate, octisalate, and octocrylene aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-054
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 g  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 g  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 g  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETYL DIMETHICONE 45 (UNII: IK315POC44)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
    POLYESTER-7 (UNII: 0841698D2F)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    STEARETH-100 (UNII: 4OH5W9UM87)  
    STEARETH-2 (UNII: V56DFE46J5)  
    YEAST MANNAN (UNII: 91R887N59P)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    CURDLAN (UNII: 6930DL209R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MELAMINE (UNII: N3GP2YSD88)  
    PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B)  
    ETHYL LINOLEATE (UNII: MJ2YTT4J8M)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ZANTHOXYLUM BUNGEANUM FRUIT (UNII: 3CIP16A418)  
    CEDRUS ATLANTICA BARK (UNII: ITP1Q41UPF)  
    PURSLANE (UNII: M6S840WXG5)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-054-211 in 1 CARTON05/01/2015
    1118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/01/2015
    Labeler - ZO Skin Health, Inc. (826468527)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest927768135MANUFACTURE(42851-054)