Label: MOISTURIZER- avobenzone cream

  • NDC Code(s): 61354-039-01, 61354-039-02
  • Packager: Oxygen Development LLC
  • 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 January 3, 2022

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  • Active ingredients

    Avobenzone 3.0%, Octinoxate 7.29%, Octocrylene 3.0%, Oxybenzone 2.0%

  • Uses

    Helps prevent sunburn

    If used as directed with other sun protections measures (see Directions), decreases the risk of skin cancer and early skin again caused by the sun

  • Warnings

    For external use only

  • Do not use

    Do not use on damage or broken skin

  • When using

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

  • Stop use

    Stop use and ask a doctor if rash occurs

  • Keep out of reach of children

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    For sunscree use: apply liberally 15 minutes sun exposure. Use a water resistant sunscreen if swimming or sweating. reapply at least every 2 hours.

    Sun protections measures. Spending time in the sun increases your risk of skin cancer and early skin again. To decrease this risk, regulary use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: lomit time in the sun, especially from 10 a.m - 2 p.m. wear long - sleeve shirts, pants, hats, and sunglasses. Children unther 6 months: ask a doctor.

  • Other information

    Protect the product in this container from excessive heat and direct sun

  • PRINCIPAL DISPLAY PANEL

    61354-039-01_AW

  • PRINCIPAL DISPLAY PANEL

    61354-039-02_AW

  • INGREDIENTS AND APPEARANCE
    MOISTURIZER 
    avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61354-039
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.29 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 4.98 g  in 100 g
    XANTHAN GUM (UNII: TTV12P4NEE) 0.2 g  in 100 g
    WATER (UNII: 059QF0KO0R) 72.61 g  in 100 g
    ISOHEXADECANE (UNII: 918X1OUF1E) 4.56 g  in 100 g
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9 g  in 100 g
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX) 0.93 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61354-039-021 in 1 CARTON01/03/2022
    1NDC:61354-039-01100 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/03/2022
    Labeler - Oxygen Development LLC (137098492)
    Establishment
    NameAddressID/FEIBusiness Operations
    Oxygen Development LLC137098492manufacture(61354-039)
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