Label: MOISTURIZER MAPLE DAY SPF15 cream

  • NDC Code(s): 63550-108-01
  • Packager: Kamins Dermatologics Inc.
  • 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 December 1, 2022

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  • Purpose section: Sunscreen

    A super emollient hydrating day cream with sunscreen to nourish deeply dry and dehydrated skin and supplement the skin’s diminished natural oils.

  • Uses:

    Helps prevent sunburn

  • Warnings

    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 sunburn, not skin cancer or early skin aging.

    For external use only.

    Do not use on damaged or broken skin.

    When using this product keep out of eyes. If contact occurs, rinse with water to remove.

    Stop use and ask a doctor if rash occurs.

    Keep out of the reach and sight of children.

    If swallowed, seek medical assistance or contact a Poison Control Center immediately.

  • Directions

    Apply liberally and evenly, each morning to cleansed face and neck, 15 minutes before sun exposure and as needed
    Reapply at least every 2 hours
    Use a water-resistant sunscreen if swimming or sweating
    Children under 6 months of ages: ask a doctor.

  • Storage:

    Protect the product in the container from excessive heat and direct sun.
    Store between 15-30 °C

  • Principal display Panel:

    B. KAMINS

    boxMoisturizer Maple day Cream SPF15

    DIN 02244222

    50mL / 1.7 fl.oz

  • INGREDIENTS AND APPEARANCE
    MOISTURIZER MAPLE DAY SPF15 
    moisturizer maple day spf15 cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63550-108
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE45 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LACTATE (UNII: TU7HW0W0QT) 50 mg  in 1 g
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) 1.7 mg  in 1 g
    CAPRYLYL GLYCOL (UNII: 00YIU5438U) 4 mg  in 1 g
    SQUALANE (UNII: GW89575KF9) 35 mg  in 1 g
    SORBIC ACID (UNII: X045WJ989B) 4 mg  in 1 g
    1,1-DIPHENYLUREA (UNII: H33D27I551) 50 mg  in 1 g
    WATER (UNII: 059QF0KO0R) 35.8 mg  in 1 g
    WHITE PETROLATUM (UNII: B6E5W8RQJ4) 80 mg  in 1 g
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I) 12.5 mg  in 1 g
    PEG-75 STEARATE (UNII: OT38R0N74H) 12.5 mg  in 1 g
    CETETH-20 (UNII: I835H2IHHX) 12.5 mg  in 1 g
    STEARETH-20 (UNII: L0Q8IK9E08) 12.5 mg  in 1 g
    RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX) 20 mg  in 1 g
    ACER SACCHARUM LEAF (UNII: VP8WP1ASR7) 50 mg  in 1 g
    TOCOPHEROL (UNII: R0ZB2556P8) 10 mg  in 1 g
    CHOLESTEROL (UNII: 97C5T2UQ7J) 10 mg  in 1 g
    MONOBASIC POTASSIUM PHOSPHATE (UNII: 4J9FJ0HL51) 4.3 mg  in 1 g
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 40 mg  in 1 g
    FRAGRANCE GREEN APPLE ORC2001072 (UNII: U9GH30P956) 2.1 mg  in 1 g
    BOVINE TYPE II COLLAGEN (TRACHEAL CARTILAGE) (UNII: 76TK29UQEZ) 40 mg  in 1 g
    CETYL ALCOHOL (UNII: 936JST6JCN) 5 mg  in 1 g
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) 15 mg  in 1 g
    SODIUM CHLORIDE DIHYDRATE (UNII: 70521YQ49G) 10 mg  in 1 g
    RETINOL (UNII: G2SH0XKK91) 0.9 mg  in 1 g
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 4 mg  in 1 g
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63550-108-0150 g in 1 BOX; Type 0: Not a Combination Product11/01/2001
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/01/2001
    Labeler - Kamins Dermatologics Inc. (254050784)
    Registrant - Odan Laboratories Ltd (208585604)
    Establishment
    NameAddressID/FEIBusiness Operations
    Odan Laboratories Ltd208585604manufacture(63550-108) , analysis(63550-108)
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