Label: LIGHT DAY SUNSCREEN BROAD SPECTRUM SPF 37- avobenzone, octinoxate and octocrylene lotion

  • 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 August 30, 2012

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  • Active ingredient

    Avobenzone 3.0%

    Octinoxate 7.5%

    Octocrylene 2.8%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn 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

    • For external use only
    • When using this product keep out of eyes. Rinse with water to remove.
    • Stop use and ask a doctor if rash occurs.
    • Do not use on damaged or broken skin
    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • apply liberally to skin 15 minutes before sun exposure and as
      needed.
    • use a water resistant sunscreen if swimming or sweating.
    • reapply at least every 2 hours.
    • children under 6 months: 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 a Broad Spectrum SPF 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 shirt, pants, hats, and sunglasses

  • Inactive ingredients

    Water, C12-15 Alkyl Benzoate, Ethylhexyl Methoxycrylene, Glycerin, Silica, Eicosene Copolymer, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Dimethicone, Cyclopentasiloxane, Cyclohexasiloxane, Dimethyl Capramide, Hydrogenated Palm Glycerides, Polysiloxane 11, Dimethylmethoxy Chromanol, Acrylamide/Sodium Acryloyldimethyl Taurate Copolymer, Diaminopropionoyl Tripeptide-33, Caprylyl Glycol, Disodium EDTA, Xanthan Gum, Methylisothiazolinone, Hexylene Glycol, Isohexadecane, Polysorbate 80, Vitis Vinifera Fruit Cell Extract, Isomalt, Prunus Armeniaca (Apricot) Fruit Extract, Lecithin, Sodium Benzoate, Aniba Rosaeodora (Rosewood) Wood Extract, Citrus Aurantifolia (Lime) Peel Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Vanilla Planifolia Fruit Extract, Citrus Grandis (Grapefruit) Peel Extract, Cocos Nucifera (Coconut) Oil

  • Other Information

    • protect this product from excessive heat and direct sun.
  • Questions?

    Call toll-free (800) 630-4710

  • Package/Label Principal Display Panel

    Light Day Sunscreen for face & neck

    Broad Spectrum SPF37

    Advanced Professional Skincare

    2 fl oz (59 ml)

    Circadia by Dr. Pugliese, Inc.
    8371 Route 183 Bethel, PA 19507
    Circadia.com

    Bottle Label

    Bottle Label

  • INGREDIENTS AND APPEARANCE
    LIGHT DAY SUNSCREEN BROAD SPECTRUM SPF 37 
    avobenzone, octinoxate and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76458-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.03 mL  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 mL  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.028 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ISOMALT (UNII: S870P55O2W)  
    APRICOT (UNII: 269CJD5GZ9)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ANIBA ROSAEODORA WOOD (UNII: NE01NKA8B2)  
    LIME PEEL (UNII: 544EQK5Q0W)  
    ORANGE PEEL (UNII: TI9T76XD44)  
    VANILLA (UNII: Q74T35078H)  
    CITRUS MAXIMA FRUIT RIND (UNII: 5NX3G75CA6)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    WINE GRAPE (UNII: 3GOV20705G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76458-201-0259 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/15/2012
    Labeler - Circadia by Dr Pugliese, Inc. (013694423)
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