Label: PLUSTEM UV PERFECT BLOCK ESSENCE- octinoxate, titanium dioxide cream

  • 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 January 24, 2019

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  • ACTIVE INGREDIENT

    Active Ingredient: ETHYLHEXYL METHOXYCINNAMATE 7.2%, TITANIUM DIOXIDE 4.4%

  • INACTIVE INGREDIENT

    Inactive Ingredients: WATER, BUTYLENE GLYCOL, CYCLOPENTASILOXANE, DICAPRYLYL CARBONATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIMETHICONE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, ISOAMYL P-METHOXYCINNAMATE, ISOHEXADECANE, CETYL PEG/PPG-10/1 DIMETHICONE, NIACINAMIDE, SODIUM CHLORIDE, SILICA, ISOSTEARIC ACID, HYDROLYZED COLLAGEN, ADENOSINE, CAMELLIA SINENSIS CALLUS CULTURE EXTRACT, NELUMBO NUCIFERA FLOWER EXTRACT, LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT, SOPHORA JAPONICA FLOWER EXTRACT, CARTHAMUS TINCTORIUS (SAFFLOWER) FLOWER EXTRACT, PYRUS COMMUNIS (PEAR) FLOWER EXTRACT, PRUNUS MUME FLOWER EXTRACT, CAMELLIA JAPONICA FLOWER EXTRACT, ZIZYPHUS JUJUBA SEED EXTRACT, SCROPHULARIA BUERGERIANA ROOT EXTRACT, OPHIOPOGON JAPONICUS ROOT EXTRACT, SCHIZANDRA CHINENSIS FRUIT EXTRACT, PANAX GINSENG ROOT EXTRACT, ANGELICA GIGAS ROOT EXTRACT, PORIA COCOS EXTRACT, ACORUS GRAMINEUS ROOT/STEM EXTRACT, ASPARAGUS COCHINCHINENSIS ROOT EXTRACT, REHMANNIA GLUTINOSA ROOT EXTRACT, PLATYCODON GRANDIFLORUM ROOT EXTRACT, CERAMIDE 3, HYDROGENATED LECITHIN, SALVIA MILTIORRHIZA FLOWER/LEAF/ROOT EXTRACT, COPTIS CHINENSIS ROOT EXTRACT, THUJA ORIENTALIS SEED EXTRACT, POLYGALA TENUIFOLIA ROOT EXTRACT, PORTULACA OLERACEA EXTRACT, SODIUM HYALURONATE, DIMETHICONE CROSSPOLYMER, GLYCERYL BEHENATE/EICOSADIOATE, XYLITOL, STEARALKONIUM HECTORITE, DEXTRIN PALMITATE, ALUMINUM HYDROXIDE, CAPRYLYL GLYCOL, POLYGLYCERYL-6 POLYRICINOLEATE, STEARIC ACID, PROPYLENE CARBONATE, CELLULOSE GUM, GLYCERIN, ZINC OXIDE, 1,2-HEXANEDIOL, ETHYLHEXYLGLYCERIN, FRAGRANCE, PHENOXYETHANOL, DISODIUM EDTA, ETHYLHEXYLGLYCERIN, IRON OXIDES(CI77492), IRON OXIDES(CI77491)

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings: 1. Please stop using the product if the following abnormal conditions exist after the application of the product. If you continue to use, it may worsen the symptom. Please consult with dermatologist. 1) When any abnormal condition exists during its use such as red spot, swelling, itching, or irritation 2) When any abnormal condition as above examples in 1) exists on the applied part by a direct sunlight 2. Please do not use the product on abnormal parts such as injured part, eczema and dermatitis. 3. Precautions for Storage and Handling a. Please make sure to close the cover after its use. b. Please keep the product out of reach by the hands of infant and children. c. Please do not store the product in the place of high or low temperature, and of direct sunlight. 4. UV protection index and UV A protection level of the present product have been measured by the standard of UV Protection Effect and Measurement Method notified by The Ministry of Foods & Drug Safety. 5. Please do not drink as the present product is cosmetics. If you drink it, please throw it up. If any abnormality exists, please consult with a doctor. Please do not put other contents in the container to use. 6. When the product stains on clothing, please do not wash it with water but with dry cleaning.

  • DESCRIPTION

    Use: In the last stage of basic touch, spread the product on face and parts (arms and legs, etc) which are easily exposed to the sun light. After drying sweat and water with towels, apply the product again as the effect of UV protection declines.

    Directions: Triple Functional Cosmetics with Whitening, Wrinkle Improvement and UV Protection Protect skin from UV (SPF50+,PA+++). It helps improve skin wrinkles. It helps lighten skin. Take proper amount of the present product and spread evenly on the skin Sun Block Lotion that creates a moisturizing natural skin tone - This lotion protects skin effectively by blocking UVA and UVB at the same time. - Components of Hyaluronic Acid and Ceramide with excellent skin moisturizing effect prevent skin from the evaporation of moisture by UV and solar heat and maintain moisturizing skin. - This lotion corrects skin tone naturally to create uniform and smooth skin tone.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    PLUSTEM UV PERFECT BLOCK ESSENCE 
    octinoxate, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71060-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.6 g  in 50 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.2 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71060-020-021 in 1 CARTON10/10/2016
    1NDC:71060-020-0150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/10/2016
    Labeler - ONA (689851847)
    Registrant - ONA (689851847)
    Establishment
    NameAddressID/FEIBusiness Operations
    ONA689851847manufacture(71060-020)