Label: FACE IT AQUA TINTED 32800420- octinoxate 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 November 20, 2014

If you are a consumer or patient please visit this version.

  • Active Ingredients

    OCTINOXATE...5.0%

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn.

  • Warnings

    For external use only.

    Do not use on damaged or broken skin.

    When using this product keep out of eyes.

    Rinse with water to remove.

    Stop use and ask a doctor if rash occurs.

    Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison

    Control Center right away.

  • Directions

    Apply generously and evenly 15 minutes before

    sun exposure.

    Children under 6 months of age: Ask a doctor

    Skin Cancer/Skin Aging Alert: Spending time

    in the sun increases your risk of skin cancer

    and early skin aging. This product has been

    shown only to help prevent sunburn, not skin

    cancer or early skin aging.

    Reapply at least every 2 hours.

    Use a water-resistant sunscreen if swimming

    or sweating.

    Apply after skincare products.

    Blend evenly with fingertips and gently pat into skin.

  • Other information

    Protect the product in this container from

    excessive heat and direct sun.

    May stain or damage some fabrics or surfaces.

  • Inactive Ingredients

    WATER•TITANIUM DIOXIDE•CYCLOMENTHICONE•

    BUTYLENE GLYCOL•HEXYL LAURATE•GLYCERIN•

    SD ALCOHOL 40-B•BIOSACCHARIDE GUM-1•

    PORTULACA OLERACEA EXTRACT•

    HYDROXYETHYL ACRYLATE/SODIUM

    ACRYLOYLDIMETHYL TAURATE COPOLYMER•

    C9-15 FLUOROALCOHOL PHOSPHATE•SQUALANE•

    PHENOXYETHANOL•TALC•METHYLPARABEN•

    ALUMINUM HYDROXIDE•ETHYLPARABEN•

    POLYSORBATE 60•BUTYLPFENYL

    METHYLPROPIONAL•HYDROXYISOHEXYL

    3-CYCLOHEXENE CARBOXALDEHYDE•LINALOOL•

    BUTYLPFENYL METHYLPROPIONAL•CITRONELLOL•

    LIMONENE•SEA WATER•PONCIRUS TRIFOLIATA

    FRUIT EXTRACT•TRIETHOXYCAPRYLYLSILANE•

    FRAGRANCE•IRON OXIDES

    (CI 77491, CI 77492, CI 77499)

  • QUESTIONS

    Questions or comments? Call 1 (866) 638-8417

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    THEFACESHOP NORTH AMERICA, INC.

    Santa Fe Springs, CA 90670

  • PRINCIPAL DISPLAY PANEL

    AQUA TINTED

    BB

    SUNSCREEN CREAM SPF20

    01 LIGHT BEIGE

    With a 70% MOISTURE CONTENT, including DEEP SEA WATER,

    a light application provides a sense of coolness and freshness the moment it touches the skin.

    FACE it

    Image-label-32800420-rev

  • INGREDIENTS AND APPEARANCE
    FACE IT AQUA TINTED  32800420
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51523-420
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 40 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51523-420-101 in 1 CARTON11/20/2014
    140 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/20/2014
    Labeler - THEFACESHOP CO., LTD. (688329416)
    Registrant - THEFACESHOP NORTH AMERICA, INC. (620459193)
    Establishment
    NameAddressID/FEIBusiness Operations
    THEFACESHOP Co., Ltd.688329416label(51523-420)