Label: SPF15 SUNSCREEN- octinoxate, oxybenzone and octisalate spray

  • NDC Code(s): 51414-600-01, 51414-600-02, 51414-600-03, 51414-600-04, view more
    51414-600-05, 51414-600-06, 51414-600-07, 51414-600-08, 51414-600-09, 51414-600-10, 51414-600-11, 51414-600-12, 51414-600-13, 51414-600-14, 51414-600-15, 51414-600-16, 51414-600-17, 51414-600-18, 51414-600-19, 51414-600-20, 51414-600-21, 51414-600-22, 51414-600-23, 51414-600-24, 51414-600-25
  • Packager: Yuyao Jessie Commodity Co.,Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 11/12

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Octinoxate 4.0%
    oxybenzone 4.0%
    Octisalate 2.0%

    Purpose

    Sunscreen

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  • Use

    Use in well ventilated areas

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  • WARNINGS

    For External use only.
    Not to be swallowed.Avoid contact with eyes.Discontinue use if signs of irritation or rash appear.Use on children under 6 months of age only with advice of a physician.Keep this and all drug out of the reach of children.In case of accidental ingestion,seek professional assistance or contact a Poision Control Center immediately

    keep out of reach of children

    Use on children under 6 months of age only with advice of a physician.Keep this and all drug out of the reach of children.

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  • Directions

    For best results ,apply 15-30 minutes before sun exposure ,Hold bottle 4-6 inches away from body and apply liberally,spraying slowly and evenly until product is visible on skin.can be applied diredtly to wet skin.reapply after swimming ,excessive perspiration,towel drying or extended sun exposure.Do not apply in windy conditions.Do not spray into face.Spray into hand and apply to the face.Use in well ventilated areas.

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  • Inactive ingredients

    ALCOHOL Denat,Glycerin ,Tocopherol ,Fragrance,Deionized WATER ,POLYSORBATE 20

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  • lebel
  • INGREDIENTS AND APPEARANCE
    SPF15 SUNSCREEN 
    octinoxate,oxybenzone,octisalate spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51414-600
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Octinoxate (OCTINOXATE) Octinoxate 4 g  in 100 g
    oxybenzone (OXYBENZONE) oxybenzone 4 g  in 100 g
    Octisalate (OCTISALATE) Octisalate 2 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL  
    glycerin  
    tocopherol  
    WATER  
    POLYSORBATE 20  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51414-600-01 5 g in 1 PACKAGE
    2 NDC:51414-600-02 7 g in 1 PACKAGE
    3 NDC:51414-600-03 8 g in 1 PACKAGE
    4 NDC:51414-600-04 10 g in 1 PACKAGE
    5 NDC:51414-600-05 12 g in 1 PACKAGE
    6 NDC:51414-600-06 15 g in 1 PACKAGE
    7 NDC:51414-600-07 20 g in 1 PACKAGE
    8 NDC:51414-600-08 25 g in 1 PACKAGE
    9 NDC:51414-600-09 30 g in 1 PACKAGE
    10 NDC:51414-600-10 40 g in 1 PACKAGE
    11 NDC:51414-600-11 50 g in 1 PACKAGE
    12 NDC:51414-600-12 60 g in 1 PACKAGE
    13 NDC:51414-600-13 70 g in 1 PACKAGE
    14 NDC:51414-600-14 80 g in 1 PACKAGE
    15 NDC:51414-600-15 90 g in 1 PACKAGE
    16 NDC:51414-600-16 100 g in 1 PACKAGE
    17 NDC:51414-600-17 120 g in 1 PACKAGE
    18 NDC:51414-600-18 130 g in 1 PACKAGE
    19 NDC:51414-600-19 150 g in 1 PACKAGE
    20 NDC:51414-600-20 160 g in 1 PACKAGE
    21 NDC:51414-600-21 180 g in 1 PACKAGE
    22 NDC:51414-600-22 200 g in 1 PACKAGE
    23 NDC:51414-600-23 220 g in 1 PACKAGE
    24 NDC:51414-600-24 250 g in 1 PACKAGE
    25 NDC:51414-600-25 300 g in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 09/12/2012
    Labeler - Yuyao Jessie Commodity Co.,Ltd. (529892305)
    Establishment
    Name Address ID/FEI Business Operations
    Yuyao Jessie Commodity Co.,Ltd. 529892305 manufacture(51414-600)
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