SUNSCREEN SPF 30 (AVOBENZONE , OCTINOXATE , ENSULIZOLE) LOTION [VIVIER PHARMA, INC.]

  • Home
  • SUNSCREEN SPF 30 (AVOBENZONE , OCTINOXATE , ENSULIZOLE) LOTION [VIVIER PHARMA, INC.]

SUNSCREEN SPF 30 (AVOBENZONE , OCTINOXATE , ENSULIZOLE) LOTION [VIVIER PHARMA, INC.]
PDF | XML
NDC 67226-2031-9
Set ID 1435d7f2-3d29-45e2-8b8f-74a0ea7ee9fa
Category HUMAN OTC DRUG LABEL
Packager Vivier Pharma, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
View All Sections
  • Drug Facts

  • Active ingredients

    Octinoxate 7.5%
    Avobenzone 2.5% 
    Ensulizole 2%

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn and provides a sun protection factor of 30.
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
    • Ideal for daily use; can be applied under makeup.
  • Warnings

    For external use only.

    Do not use

    on damaged or broken skin.

    When using this product

    avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if

    rash or irritation develops and lasts.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply daily to face, neck and chest.
    • Apply liberally and evenly 15 minutes before sun exposure.
    • Reapply at least every 2 hours.
    • For use on children less than 6 months of age, consult a healthcare practitioner.
    • Use a water resistant sunscreen if swimming or sweating.
    • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. to 2 p.m. and wear long-sleeved shirts, pants, hats, and sunglasses.
  • Other information

    Store at room temperature (15-30°C / 59-86°F).

  • Inactive ingredients

    Butylated Hydroxytoluene, Butylparaben, Carbomer, Cetyl Alcohol, Dimethicone, Disodium EDTA, D-Panthenol, Ethylparaben, Hydrogenated Palm Glycerides, Methylparaben, Octyldodecanol, Octyldodecyl Neopentanoate, Phenoxyethanol, Potassium Cetyl Phosphate, Propylene Glycol, Propylparaben, Sodium Hydroxide, Stearic Acid, Tocopheryl Acetate, Triethanolamine, Water.

  • Questions?

    Call 1 877 484 8437

  • Package Labeling:

    Outer PackageInner Package

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN  SPF 30
    avobenzone , octinoxate , ensulizole lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67226-2031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 mL
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67226-2031-990 mL in 1 TUBE; Type 0: Not a Combination Product07/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/01/2018
    Labeler - Vivier Pharma, Inc. (250996550)
View All Sections

Related Drugs

Search DailyMed Drugs