CAMOUFLAGE CONCEALER CREAM (OCTINOXATE) CREAM [RIPAR COSMETICI SRL]

CAMOUFLAGE CONCEALER CREAM (OCTINOXATE) CREAM [RIPAR COSMETICI SRL]
PDF | XML

NDC 72399-102-01, 72399-102-02
Set ID 6f38c762-3a53-b103-e053-2a91aa0ae63c
Category HUMAN OTC DRUG LABEL
Packager Ripar Cosmetici srl
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENTS PURPOSE

    Oxtinoxate 2% sunscreen

    box

  • Warnings

    SUN ALERT: Limiting sun exposures, wearing protective clothing and using sunscreens may reduce the risks of skin aging. skin cancer, and other harmful effects of the sun

    For external use only.

    Do not use on damaged or broken skin.

    When using this product keep our of the eyes. Rinse with water to remove.

    SUN PROTECTION MEASURES. Spending times 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 15 or higher and other sun protection measures including: limit time to the sun especially from 10:00 am to 2:00 pm. Weat long sleeve shirts , pants, hats and sunglasses

    DIscontinue uses if signs or irritationsor rash appears. If irritation or rash persists, consult with a doctor.

    Keep out of reach of children. If swallowed, get medical help or Contact Poison Control Central right away

    Children under 6 months ask a doctor

    WARNINGS

    Children under 6 months: ask a doctor

    Warnings

    Keep out of reach of children

  • Questions or comments?

    1- 800-775-1827. M-F 9:00 am to 5:00 pm EST

    www.ripar.us

  • Other Information

    Protect this product from excessive heat and direct sun

  • Directions

    • provides minimun protection against sunburn
    • if used as directed with other sun protection measures (see directions), decreases the risks of skin cancer and early skin aging caused by the sun

    • apply liberally 15 minutes before sun exposure reapply adter 40 or 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours
    • children under 6 months of age, consult with a doctor
  • Uses

    • provides minimun protection against sunburn
    • if used as directed with other sun protection measures (see directions), decreases the risks of skin cancer and early skin aging caused by the sun

  • Inactive Ingredients

    CAPRYLIC/CAPRIC TRIGLYCERIDE, MEDIUM CHAIN TRIGLYCERIDES, BEESWAX YELLOW WAX, CANDELILLA WAX, OCTINOXATE, DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE, MAGNESIUM CARBONATE, SILICON DIOXIDE, HYDROGENATED PALM, MICA, TOCOPHEROL , PHENOXYETHANOL, FERRIC OXIDE YELLOW , FERRIC OXIDE RED, TITANIUM DIOXIDE, FD&C YELLOW No. 5, D&C RED No. 36

  • Uses

    • provides minimun protection against sunburn
    • if used as directed with other sun protection measures (see directions), decreases the risks of skin cancer and early skin aging caused by the sun
  • Package Label

    pRODUCT

  • INGREDIENTS AND APPEARANCE
    CAMOUFLAGE CONCEALER CREAM 
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72399-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE (UNII: D21K655H52)  
    MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROGENATED PALM OIL (UNII: 257THB963H)  
    MICA (UNII: V8A1AW0880)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    D&C RED NO. 36 (UNII: OE8ZA0KN9Z)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72399-102-021 in 1 BOX06/19/2018
    1NDC:72399-102-014 mL in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/19/2018
    Labeler - Ripar Cosmetici srl (338675564)
    Registrant - Ripar Cosmetici srl (338675564)
    Establishment
    NameAddressID/FEIBusiness Operations
    338675564338675564manufacture(72399-102)

Related Drugs