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OP Dark Formula Xtreme Tanning 4 (Sun & Skin Care Research, LLC)

Available Formats

Dosage Form Package Information Links
LOTION 251 mL in 1 BOTTLE (62802-600-08) Label Information

Complete OP Dark Formula Xtreme Tanning 4 Information

  • Active Ingredients

    Octinoxate 3.0%
    Octisalate 2.0%
  • Purpose

    Sunscreen


  • 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 prevent sunburn, not skin cancer or early skin aging.

    For external use only.  Do not use on damaged or broken skin.  Stop use and ask a doctor if rash occurs.  When using this product keep out of eyes.  Rinse with water to remove.  Keep out of the reach of children.  If swallowed, get medical help or call a poison control center right away.


  • Directions

    • apply evenly and liberally to all exposed areas 15 minutes before sun exposure.  Ensure skin is completely covered with product.
    • reapply after 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours
    • children under 6 months:  Ask a doctor

  • Other Information

    • protect this product from excessive heat and direct sun
    • for use on skin only
    • avoid contact with fabric

  • INGREDIENTS AND APPEARANCE
    OP DARK FORMULA XTREME TANNING 4 
    octinoxate, octisalate lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62802-600
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    CARAMEL (UNII: T9D99G2B1R)  
    CANOLA OIL (UNII: 331KBJ17RK)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYISOBUTYLENE (2300 MW) (UNII: DSQ2V1DD1K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62802-600-08 251 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 01/01/2012
    Labeler - Sun & Skin Care Research, LLC (849772207)
    Establishment
    Name Address ID/FEI Business Operations
    Sun & Skin Care Research, LLC 849772207 manufacture