ULTIMATE AQUA BLANC PROTECTIVE (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE) LOTION [RACINNE (HONG KONG) LIMITED]

ULTIMATE AQUA BLANC PROTECTIVE (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE) LOTION [RACINNE (HONG KONG) LIMITED]
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NDC 69015-100-01
Set ID fe06a496-9627-49f7-820d-7d3eb7d30b79
Category HUMAN OTC DRUG LABEL
Packager Racinne (Hong Kong) Limited
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredients: Ethylhexyl Methoxycinnamate 7.5%, Ethylhexyl Salicylate 5%, Octocrylene 4%, Butyl Methoxydibenzoylmethane 3%

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:
    AQUA, BUTYLENE GLYCOL, METHYL METHACRYLATE CROSSPOLYMER, SILICA, CAPRYLIC/ CAPRIC TRIGLYCERIDE, NIACINAMIDE, GLYCERYL STEARATE, CETEARYL OLIVATE, CETEARYL ALCOHOL, SORBITAN OLIVATE, DIMETHICONE, PEG-100 STEARATE, POLY-SORBATE 60, NELUMBO NUCIFERA CALLUS CULTURE EXTRACT, XANTHAN GUM, PHENOXYETHANOL, TOCOPHERYL ACETATE, FRAGRANCE, SODIUM BENZOATE, POLYACRYLATE-13, SORBITAN STEARATE, DISODIUM EDTA, ROYAL JELLY EXTRACT, PEARL EXTRACT, GLYCERIN, POLYISOBUTENE, POTASSIUM SORBATE, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, NELUMBO NUCIFERA FLOWER EXTRACT, BHT, PROPYLENE GLYCOL, VACCINIUM MACROCARPON (CRANBERRY) FRUIT EXTRACT, OLEA EUROPAEA (OLIVE) LEAF EXTRACT, EQUISETUM ARVENSE EXTRACT, ADANSONIA DIGITATA SEED EXTRACT, SORBITAN ISOSTEARATE, POLYSORBATE 20, USNEA BARBATA (LICHEN) EXTRACT, ZANTHOXYLUM PIPERITUM FRUIT EXTRACT, PULSATILLA KOREANA EXTRACT, VERONICA OFFICINALIS EXTRACT, PRIMULA VERIS EXTRACT, MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT, MELISSA OFFICINALIS LEAF EXTRACT, MALVA SYLVESTRIS (MALLOW) EXTRACT, ALCHEMILLA VULGARIS EXTRACT, ACHILLEA MILLEFOLIUM EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, SOPHORA JAPONICA FLOWER EXTRACT, SODIUM HYALURONATE, FRUCTAN, CAPRYLYL GLYCOL, ACETYL TYROSINE, 1,2- HEXANEDIOL, PAEONIA SUFFRUTICOSA ROOT EXTRACT, PUERARIA LOBATA ROOT EXTRACT, ETHYLHEXYLGLYCERIN

  • PURPOSE

    Purpose: Sun Protective Lotion

  • WARNINGS

    Warnings:
    Store in a cool environment.
    Avoid contact with eyes.
    In case of contact with eyes, rinse thoroughly with water.
    If you experience any discomfort or allergic reaction after use, cease use immediately and consult with a doctor or skincare professional.
    For external use only.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS AND USAGE

    Indications and usage:
    After cleansing and toning regimen, apply a small amount onto face and neck area before exposing to outdoor sunlight, avoiding eye area.
    For optimal results, use after Ultimate Aqua Blanc Concentrate for an enhanced brightened complexion.

  • DOSAGE AND ADMINISTRATION

    Dosage and administration:
    Take an adequate amount of this product.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    ULTIMATE AQUA BLANC PROTECTIVE 
    octinoxate, octisalate, octocrylene, avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69015-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 mg  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.5 mg  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 mg  in 50 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69015-100-0150 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/2014
    Labeler - Racinne (Hong Kong) Limited (663588145)
    Registrant - Racinne (Hong Kong) Limited (663588145)
    Establishment
    NameAddressID/FEIBusiness Operations
    Racinne (Hong Kong) Limited663588145manufacture(69015-100)

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