Label: LANOCREME HYDRATING DAY SPF15- avobenzone, oxybenzone, octyl methoxycinnamate 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 April 27, 2012

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS
    Avobenzone 3%
    Oxybenzone 3%
    Octylmethoxycinnamate 7.5%

  • DOSAGE & ADMINISTRATION

    DIRECTIONS
    Apply liberally and evenly 15 minutes before sun exposure
    Children under 6 months of age: Ask a doctor
    Apply to all skin exposed to the sun
    Reapply at least every 2 hours
    Use a water resistant sunscreen if swimming or sweating

  • WARNINGS

    WARNINGS
    For external use only. Do not use on broken or damaged skin.
    Skin Cancer/Skin Ageing Alert: Spending time in the sun increases your risk of skin cancer and early skin ageing. This product has been shown only to help prevent sunburn, not skin cancer or early skin ageing.

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

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

    Stop use and ask a doctor if any rush occurs.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    Water
    Ethylhexyl palmitate
    Caprylic triglyceride
    Capric triglyceride
    Polyacrylamide
    c13-14 Isoparaffin
    Laureth-7
    Polysorbate 60
    Cetearyl alcohol
    Glycerin
    Cyclopentasiloxane
    Clyclotetrasiloxane
    dimethiconol
    Caprylhydroxamic acid
    phenoxyethanol
    methylpropanediol
    tocopheryl acetate (vitamin e)
    lanolin (medical grade)
    Sorbitan stearate
    Hydrolyzed (Marine) collagen
    Tetrasodium EDTA
    Actinidia chinensis (kiwi) fruit extract
    Leptospermum scoparium Mel UMF 15+ Active Manuka Honey

  • PRINCIPAL DISPLAY PANEL


    Outer label Image

    Inner label image

  • INGREDIENTS AND APPEARANCE
    LANOCREME HYDRATING   DAY SPF15
    avobenzone, oxybenzone, octyl methoxycinnamate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43617-3415
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.5 g  in 50 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1.5 g  in 50 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Ethylhexyl palmitate (UNII: 2865993309)  
    Tricaprylin (UNII: 6P92858988)  
    Tricaprin (UNII: O1PB8EU98M)  
    SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)  
    C13-14 Isoparaffin (UNII: E4F12ROE70)  
    Laureth-7 (UNII: Z95S6G8201)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Glycerin (UNII: PDC6A3C0OX)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Cyclomethicone 4 (UNII: CZ227117JE)  
    Dimethiconol (41 MPA.S) (UNII: 343C7U75XW)  
    Caprylhydroxamic acid (UNII: UPY805K99W)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Methylpropanediol (UNII: N8F53B3R4R)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Lanolin (UNII: 7EV65EAW6H)  
    Sorbitan monostearate (UNII: NVZ4I0H58X)  
    HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW) (UNII: 2WID9OCG7P)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    KIWI FRUIT (UNII: 71ES77LGJC)  
    HONEY (UNII: Y9H1V576FH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43617-3415-11 in 1 BOX
    150 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/30/2012
    Labeler - Lanocorp Pacific Ltd (594482114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lanocorp Pacific Ltd594482114manufacture
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