Label: SKIN CARE PRESCRIPTION- avobenzone,octocrylene,oxybenzone,homosalate,octisalate lotion

  • 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 October 18, 2010

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  • PRINCIPAL DISPLAY PANEL

    Active Ingredients:                                                                                                   Purpose
    Avobenzone 3.0%...................................................................................................Sunscreen (A)
    Octocrylene  4.0%...................................................................................................Sunscreen (B)
    Oxybenzone 6.0%...................................................................................................Suncreeen (A)
    Homosalate  15.0%.................................................................................................Sunscreen (B)
    Octisalate     5.0%...................................................................................................Sunscreen (B)


  • Uses

    • High UVB sunburn/UVA protection
    • for skin highly sensitive to sunburn
    • retains SPF after 80 minutes of activity
  • Warnings

    For External use only
    UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using sunscreen.
  • Directions

    • Apply liberally before sun exposure.
    • Apply and reapply as directed to avoid lowering protection.
    • Reapply after 80 minutes of swimming or sweating and after towel drying. Otherwise reapply at least every 2 hours.
    • Children under 6 months; ask a doctor.
  • Inactive Ingredients

    Aqua; Acrylates/C10-30 Alkyl Acrylate Crosspolymer; Sorbitol; Marshmellow Extract,; Ivy Extract; Cucumber Extract; Elder Flower; Arnica Extract; EDTA; Aloe Barbadensis Leaf Juice; Isopropyl Palmitate; Stearic Acid; PEG100 Stearate; Dimethicone; Tocopheryl Acetate; Cetyl Alcohol; Glyceryl Stearate; C12-15 Alkyl Benzoate; Cetearyl Alcohol, Ceteareth-20; DMDM Hydantoim; Phenoxyethanol Ethylhexyl Glycerin; Triethanolamine; Acrylates/C12-22 Alkylmethacrylates Copolymer; Retinyl Palmitate

  • PRINCIPAL DISPLAY PANEL

    image of tube label


  • WHEN USING

    When using this product keep out of eyes.

    Rinse with water to remove.

    May stain some fabrics
  • KEEP OUT OF REACH OF CHILDREN

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

    Stop use and ask a doctor if skin rash occurs.

  • INGREDIENTS AND APPEARANCE
    SKIN CARE PRESCRIPTION 
    avobenzone,octocrylene,oxybenzone,homosalate,octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52347-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3.40 g  in 114.4 g
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate17.01 g  in 113.4 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.06 g  in 113.4 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.05 g  in 113.4 g
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene4.54 g  in 113.4 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERYL DISTEARATE (UNII: 73071MW2KM)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
    ACAI (UNII: 46AM2VJ0AW)  
    CRANBERRY (UNII: 0MVO31Q3QS)  
    CUCUMBER (UNII: YY7C30VXJT)  
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52347-111-01116 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/23/2010
    Labeler - Skin Care Physicians, Inc. (064598985)
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