EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]

EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]
PDF | XML

NDC 69219-103-13, 69219-103-15, 69219-103-28, 69219-103-51, 69219-103-55
Set ID ecc4d304-e7e2-45b6-b9b2-2c64d3630860
Category HUMAN OTC DRUG LABEL
Packager SCIENCE OF SKINCARE LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Octinoxate – 5.50%

    Zinc Oxide – 4.12%

  • PURPOSE

    SUNSCREEN

  • USES

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

  • WARNINGS

    • For external use only

  • DO NOT USE

    • Do not use on damaged or broken skin

  • WHEN USING

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

  • STOP USE

    • Stop use and ask a doctor if rash occurs

  • KEEP OUT OF REACH OF CHILDREN

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

    • APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.

    • Use a water resistant sunscreen if swimming or sweating

    • Reapply at least every 2 hours

    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
    o limit time in the sun, especially from 10 a.m.-2 p.m.
    o wear long-sleeve shirts, pants, hats, and sunglasses
    • Children under 6 months: Ask a doctor

  • Other Information

    PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

  • Questions or Comments?

    Call Customer Care at (888) 804-4447

  • Inactive Ingredients

    Water, Polyacrylamide, Tocopherol, Ethylhexyl Palmitate, PPG-3 Myristyl Ether, Cetyl Alcohol, Glycol Stearate SE, VP/Hexadecene Copolymer, Olea Europaea (Olive) Leaf Extract, Aloe Barbadensis Leaf Juice, Asiaticoside, Asiatic Acd, Madecassic Acid, Sodium Dihydrocetyl Phosphate, Ethyl Linoleate, Oleyl Alcohol, Glyceryl Stearate, Octyldodecyl Neopentanoate, Caprylyl Glycol, Hexylene Glycol, PEG-100 Stearate, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol.

  • Package Label - Principal Display Panel

    5g Pack NDC 69219-103-555g Label NDC 69219-103-15100g Box NDC 69219-103-51100g Label NDC 69219-103-13240g Label NDC 69219-103-28

  • INGREDIENTS AND APPEARANCE
    EXTREME PROTECT SPF 30 
    octinoxate, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69219-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5.5 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4.12 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    PPG-3 MYRISTYL ETHER (UNII: 7913J43WZ5)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCOL STEARATE SE (UNII: 6YLY96TQL6)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ASIATICOSIDE (UNII: PKO39VY215)  
    ASIATIC ACID (UNII: 9PA5A687X5)  
    MADECASSIC ACID (UNII: M7O1N24J82)  
    SODIUM DIHYDROXYCETYL PHOSPHATE (UNII: YWI33EV595)  
    ETHYL LINOLEATE (UNII: MJ2YTT4J8M)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69219-103-511 in 1 BOX10/01/2014
    1NDC:69219-103-13100 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:69219-103-551 in 1 BOX10/01/2014
    2NDC:69219-103-155 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    3NDC:69219-103-28240 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2014
    4NDC:69219-103-13100 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2014
    5NDC:69219-103-155 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/01/2014
    Labeler - SCIENCE OF SKINCARE LLC (006251958)

Related Drugs