Label: LYCORIS RUBUS BRIGHTENING BB SPF40 PA PLUS PLUS- octinoxate, titanium dioxide, zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL

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 October 7, 2013

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  • ACTIVE INGREDIENT

    Active Ingredients: Ethylhexyl methoxycinnamate 7.5%, Titanium dioxide 5%, Zinc oxide 5%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Cyclopentasiloxane, Butylene glycol, Isoamyl p-methoxycinnamate, Cetyl PEG/PPG-10/1 Dimethicone, Betaine, Cetyl ethylhexanoate, Polysorbate 60, Dimethicone, Sodium chloride, Sodium hyaluronate, PEG-40 stearate, Iron oxides, Bentonite, Talc, Stearic acide, Phenoxyethanol, Methylparaben, Ethylparaben, Butylparaben, Propylparaben, Isobutylparaben, Tocopheryl acetate, Perfume, Rubus hirsutus fruit/leaf extract, Camellia Japonica Ovary Powder, Centella asiatica extract, Lavandula angustifolia (Lavender) extract, Glycyrrhiza glabra (Licorice) root extract, Triticum vulgare (Wheat) flour lipids, Allantoin, Lysine HCL, Disodium EDTA, Proline, Sodium ascorbyl phosphate, Linum usitatissimum (Linseed) seed extract, Hibiscus esculentus fruit extract, Aloe barbadensis leaf juice, Arctium lappa root extract, Hibiscus mutabilis flower extract, Corchorus olitorius leaf extract, Dimethyl sulfone

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings: 1. In case of having following symptoms after using this, you’re advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problem such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In the case of getting it into your eyes, you have to wash it immediately.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of babies and children

  • INDICATIONS AND USAGE

    Indications and usage: 1. Tighten the lid after using it. 2. Don’t keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight. 3. Use it in the evening after washing face.

  • DOSAGE AND ADMINISTRATION

    Dosage and administration: Apply after washing face. Take a small amount of cream about 1.0-1.5g on to the fingertips and gently massage over the entire face.(cheeks, nostrils, corners, forehead, and the around of eyes, even your hands) Blot face lightly with tissue, and may sleep without washing it.

  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    LYCORIS RUBUS BRIGHTENING BB  SPF40 PA PLUS PLUS
    octinoxate, titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60778-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3 mg  in 40 mL
    Titanium dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium dioxide2 mg  in 40 mL
    Zinc oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2 mg  in 40 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60778-010-0140 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2013
    Labeler - Lycoris Co., Ltd. (688301521)
    Registrant - Lycoris Co., Ltd. (688301521)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lycoris Co., Ltd.688301521manufacture(60778-010)