Label: SUDDEN CHANGE INTENSIVE RESTORATION DAILY MOISTURIZER SPF 15 - zinc oxide and octinoxate cream 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/11

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  • Drug Facts

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  • Active Ingredients

    ZINC OXIDE 2.00%..............................SUNSCREEN
    OCTINOXATE 6.00%............................SUNSCREEN

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  • Purpose

    SUNSCREEN

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  • Uses

    ■ Helps prevent sunburn
    ■ Higher SPF gives more sunburn protection

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  • Warnings


    ■ Sun Alert: 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 a sunscreen.

    ■ For external use only

    ■ When using this product, keep out of eyes

    ■ Stop use and ask a doctor if rash or irritation develops and lasts

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  • KEEP OUT OF REACH OF CHILDREN

    ■ Keep out of reach of children

    ■ If swallowed, get medical help or contact a Poison Control Center immediately

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  • Directions

    ■ Do not shake before using
    ■ To dispense the product, point the opening of the bottle into your cupped hand and slowly and carefully press the pump until you have the desired amount of product
    ■ Gently apply cream to face and neck daily
    ■ May be used alone or under makeup

    ■ Note: If an excessive amount of product is dispensed, reduce the amount of pressure on the pump for future applications

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  • Inactive Ingredients

    ALLANTOIN, ALOE BARBADENSIS LEAF EXTRACT, BISABOLOL, BUTYLENE GLYCOL, C12-15 ALKYL BENZOATE, CAMELLIA SINENSIS EXTRACT, CAPRYLIC/CAPRIC TRIGLYCERIDE, CARPRYLYL GLYCOL, CERAMIDE, CETEARYL OLIVATE, CETYL ALCOHOL, CITRUS AURANTIUM AMARA FLOWER EXTRACT, DIMETHICONE, DISODIUM EDTA, GLYCERIN, HEXYLENE GLYCOL, HYDROGENATED OLIVE OIL, OLEA EUROPAEA (OLIVE) FRUIT OIL, OLEA EUROPAEA (OLIVE) FRUIT OIL UNSAPONIFIABLES, PALMITOYL OLIGOPEPTIDE, PEG-10 RAPESEED STEROL, PENTYLENE GLYCOL, PHENOXYETHANOL, POTASSIUM SORBATE, SIMMONDSIA CHINENSIS (JOJOBA) OIL, SODIUM HYALURONATE, SORBITAN OLIVATE, TETRAHEXYLDECYL ASCORBATE, TOCOPHERYL ACETATE, TRIBEHENIN, TRIETHOXYCAPRYLYLSILANE, WATER (AQUA), XANTHAN GUM.

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  • Questions or Comments?

    Call 1-800-595-6230
    Report any issues associated with this product to the telephone number or address listed on this package

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  • Sudden Change Intensive Restoration Daily Moisturizer SPF 15

    Nothing damages your skin as much as exposure to the sun. Whether it’s prolonged exposure or just a few minutes a day, the sun causes leathery texture, uneven skin tone and brown spots, as well as lines and wrinkles.

    This is the daily moisturizer that you and your sun-damaged skin have been waiting for.Sudden Change Intensive Restoration Daily Moisturizer has been exclusively formulated to help repair visible signs of sun damage, including sun spots, leathery texture and uneven skin tone. It works below the immediate surface of the skin to dramatically improve the look and feel of your skin like nothing else you have ever tried.Skin will look smoother, healthier and beautifully luminous.

    Derma-Corrective Complex is a unique combination of essential ingredients that help restore sun damaged skin. This exclusive complex, with Oligopeptides, Ceramides and Antioxidants, absorbs on
    contact to quickly begin repairing the skin’s natural dermal barrier to help reverse the appearance of sun damage.

    ■ Oligopeptides and Hyaluronic help reverse visible signs of sun damage.

    ■ Super antioxidants are known to neutralize free radicals and help speed natural skin repair.

    ■ Ceramides and Jojoba are known to help restore skin’s natural defense barrier.

    ■ Sunscreen with zinc oxide helps shield and protect skin from further sun damage.

    For best results, use Sudden Change Intensive Restoration Daily Moisturizer in place of your regular facial moisturizer all year round. Also, apply after prolonged sun exposure. You’ll love the look of your smoother, beautifully luminous skin.

    Sun Alert: 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 a sunscreen.

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  • Sudden Change Intensive Restoration Daily Moisturizer SPF 15 50ml
  • INGREDIENTS AND APPEARANCE
    SUDDEN CHANGE INTENSIVE RESTORATION DAILY MOISTURIZER SPF 15 
    zinc oxide, octinoxate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:61543-1082
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 2 mL  in 100 mL
    OCTINOXATE (OCTINOXATE) OCTINOXATE 6 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALLANTOIN  
    ALOE VERA LEAF  
    LEVOMENOL  
    BUTYLENE GLYCOL  
    ALKYL (C12-15) BENZOATE  
    GREEN TEA LEAF  
    MEDIUM-CHAIN TRIGLYCERIDES  
    CAPRYLYL GLYCOL  
    CETEARYL OLIVATE  
    CETYL ALCOHOL  
    CITRUS AURANTIUM FLOWER  
    DIMETHICONE  
    EDETATE DISODIUM  
    GLYCERIN  
    HEXYLENE GLYCOL  
    OLIVE OIL  
    PALMITOYL OLIGOPEPTIDE  
    PEG-10 RAPESEED STEROL  
    PENTYLENE GLYCOL  
    PHENOXYETHANOL  
    POTASSIUM SORBATE  
    JOJOBA OIL  
    HYALURONATE SODIUM  
    SORBITAN OLIVATE  
    TETRAHEXYLDECYL ASCORBATE  
    TRIBEHENIN  
    TRIETHOXYCAPRYLYLSILANE  
    WATER  
    XANTHAN GUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61543-1082-2 50 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 09/18/2011
    Labeler - CCA Industries Inc (106771041)
    Establishment
    Name Address ID/FEI Business Operations
    CSR Cosmetic Solutions Inc. 243501959 manufacture
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