Label: DEARDERM DAILY MOSITURE SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 21, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Homosalate 15%, Oxybenzone 6%, Octisalate 5% Avobenzone 3%,t Octocrylene 2.4%

  • Purpose

    Sunscreen

  • Use

    helps prevent sunburn.

  • Warnings

    • For external use only

    When using this product

    • Do not get it into eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if Irritation or rash develops

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

  • Directions

    • Apply generous amount evenly to all areas 15 minutes before sun exposure
    • Reapply at frequent intervals and after swimming or towel drying
    • Ask a doctor before use on infants under six months of age
  • Other Information

    • May Stain some materials
  • Inactive Ingredients

    Water (Aqua), Stearyl Alcohol, Cetyl Alcohol, Glyceryl Stearate (and) Peg-100 Stearate, Ethylhexyl Palmitate, Dimethicone, Paraffinum Liquidum, Phenoxyethanol, Aloe Barbadensis Leaf Juice, PVP, Menthone Glycerin Acetal, Triethanolamine, Carbomer, Fragrance, PEG-8, Disodium EDTA, Ethylhexylglycerin, Tocopheryl Acetate, Retinyl Palmitate.

  • SPL UNCLASSIFIED SECTION

    Distributed by
    Rainbow Beauty Company

    Manufactured by
    Samson Pharmaceuticals Inc.

  • PRINCIPAL DISPLAY PANEL - 88 mL Tube Label

    Daily Moist
    Sunscreen
    For Family

    DEARDERM

    SPF
    50+
    PA+++

    BROAD SPECTRUM
    UVA/UVB Protection

    ALOE VERA & VITAMIN B

    Reduces the Appearance of Photo-Aging

    88 mL / 3 fl oz

    PRINCIPAL DISPLAY PANEL - 88 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    DEARDERM DAILY MOSITURE SUNSCREEN 
    avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72279-078
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate150 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene24 mg  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72279-078-0188 mL in 1 TUBE; Type 0: Not a Combination Product06/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35206/01/2018
    Labeler - RAINBOW BEAUTY COMPANY (012749151)
    Establishment
    NameAddressID/FEIBusiness Operations
    Samson Pharmaceuticals Inc.088169581MANUFACTURE(72279-078)
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