Label: DAY HYDRATOR SPF-15- octinoxate and octisalate and oxybenzone 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 May 10, 2010

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:

    Ethylhexyl Methoxycinnamate - 7.5%
    Ethylhexyl Salicylate - 5.0%
    Benzophenone-3 - 3.0%
  • DOSAGE & ADMINISTRATION

    DIRECTIONS: In the morning, gently apply a small amount of moisturizer onto clean face and neckfor daily hydration and skin protection.
  • GENERAL PRECAUTIONS

    CAUTION: Discontinue use if redness or rash occurs. Seek medical attention if irritation persists.
  • WARNINGS

    WARNING: For external use only.
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.
  • PRINCIPAL DISPLAY PANEL

    GiGi ORGANICS
    Natural Skincare System

    DAY HYDRATOR
    SPF 15

    Honey
    Sunflower
    Green Tea
    GiGi SPF-15 Hydrator Tube Artwork
    GiGi SPF-15 Hydrator UC Artwork



  • INGREDIENTS AND APPEARANCE
    DAY HYDRATOR  SPF-15
    octinoxate and octisalate and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57367-027
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    MYRISTYL LAURATE (UNII: 58U0NZN2BT)  
    ALLANTOIN (UNII: 344S277G0Z)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    HELIANTHUS ANNUUS (UNII: BKJ0J3D1BP)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    HONEY (UNII: Y9H1V576FH)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    BELLIS PERENNIS (UNII: 2HU33I03UY)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    HIBISCUS SABDARIFFA CALYX (UNII: 584J2XT260)  
    JASMINE (UNII: 0Q8K841432)  
    LAVENDER (UNII: 9YT4B71U8P)  
    ROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57367-027-191 in 1 CARTON
    1NDC:57367-027-1856 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2006
    Labeler - 220 Laboratories Inc. (783247950)
    Registrant - 220 Laboratories Inc. (783247950)
    Establishment
    NameAddressID/FEIBusiness Operations
    220 Laboratories Inc.783247950manufacture
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