DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]

DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]
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NDC 57367-027-18, 57367-027-19
Set ID 23a8e7af-802b-48a0-93b9-a3665a12254b
Category HUMAN OTC DRUG LABEL
Packager 220 Laboratories Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • 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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