Label: PATRICKS SUNSCREEN- avobenzone, octinoxate, octocrylene, 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 16, 2012

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  • Active ingredients.............

    Avobenzone 2.0%, Octinoxate 7.25%, Octocrylene 9.75%, Oxybenzone 3.0%

  • Uses

    • Helps prevent sunburn
    • Higher SPF gives more sunburn protection
    • High protection against sunburn and tanning
    • Retains SPF after 40 minutes of activity in the water or sweating
  • Warnings

    • For external use only. When using this product
    • Keep out of eyes
    • Rinse with warm water to remove.  Stop use and ask doctor if
    • rash or irritation develops and lasts
  • Directions

    • Apply liberally 30 minutes before sun exposure
    • Children under 6 months of age consult a doctor
    • Reapply as needed or after towel drying, swimming or sweating
  • Purpose

    Purpose...............Sunscreen

  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
  • Inactive ingredients

    Water (Aqua), C12-15 Alkyl Benzoate, Acrylates/C12-22 Alkyl Methacrylate Copolymer (Waterproofing), Aloe Barbadensis (Aloe Vera) Leaf Juice, Isododecane, Phenoxyethanol (Preservative), Fragrance (Parfum), Tetrasodium EDTA, Carbomer, Triethanolamine, Sorbitan Oleate (Plant Derived), Tocopheryl Acetate (Vitamin E Acetate), Retinyl Palmitate (Vitamin A Palmitate), Cereus Grandiflorus (Cactus) Flower Extract, Methylisothiazolinone.

    Questions or comments: 1-800-411-8801 . patrickssunscreen.com

  • PRINCIPAL DISPLAY PANEL

    Place holder text.

    image of front of packageimage of back of package

  • INGREDIENTS AND APPEARANCE
    PATRICKS SUNSCREEN 
    avobenzone, octinoxate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40061-990
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone2 g  in 100 g
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.25 g  in 100 g
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene9.75 g  in 100 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Isododecane (UNII: A8289P68Y2)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Edetate Sodium (UNII: MP1J8420LU)  
    Carbomer Copolymer Type A (UNII: 71DD5V995L)  
    Trolamine (UNII: 9O3K93S3TK)  
    Sorbitan Monooleate (UNII: 06XEA2VD56)  
    Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    Selenicereus Grandiflorus Flower (UNII: II877K4UNR)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40061-990-088 in 1 CELLO PACK
    1NDC:40061-990-108.75 g in 1 PACKET
    2NDC:40061-990-5050 in 1 BOX
    2NDC:40061-990-108.75 g in 1 PACKET
    3NDC:40061-990-118.75 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/28/2011
    Labeler - O.P. Products, Inc. (840571231)
    Establishment
    NameAddressID/FEIBusiness Operations
    O.P. Products, Inc.840571231relabel
    Establishment
    NameAddressID/FEIBusiness Operations
    G.A.R. Laboratories, Inc.074933615manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    LICO Industries, LLC098009041repack
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