Label: SPF 30 SUNSCREEN- octinoxate, oxybenzone and octisalate spray 

  • Label RSS
  • NDC Code(s): 57817-300-01, 57817-300-02, 57817-300-03, 57817-300-04, view more
    57817-300-05, 57817-300-06, 57817-300-07, 57817-300-08, 57817-300-09, 57817-300-10, 57817-300-11, 57817-300-12, 57817-300-13, 57817-300-14, 57817-300-15, 57817-300-16, 57817-300-17, 57817-300-18, 57817-300-19, 57817-300-20, 57817-300-21, 57817-300-22, 57817-300-23, 57817-300-24, 57817-300-25, 57817-300-26, 57817-300-27, 57817-300-28, 57817-300-29, 57817-300-30, 57817-300-31, 57817-300-32, 57817-300-33, 57817-300-34, 57817-300-35, 57817-300-36, 57817-300-37, 57817-300-38, 57817-300-39, 57817-300-40
  • Packager: Hangzhou Haorun Technology 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 03/13

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

  • Active Ingredient

    Octinoxate 6.0%

    Oxybenzone 4.0%

    Octisalate 5.0%

    sunscreen

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  • Use

    Protection from the sun’s damaging effects.

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  • Warnings

    For external use only.Not to be swallowed.Avid contact with eyes.Discontinue use if signs  or 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 assisitance or contact and Poision Control Center imdediately.

    Do not use near fire,Store at temerature below 120F(48).Use only as directed.intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

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  • Direction

    For best results,apply 15-30 minutes befroes 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 directly to wet skin.Reapply after swimming,excessive perspiration,towel drying or extended sunexposure .Don 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 Ingredient

    Alcohal Denat,Glycerin,Tocopherol,Fragrance,Deionized Water,Polysorbate-20

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  • INGREDIENTS AND APPEARANCE
    SPF 30 SUNSCREEN 
    octinoxate oxybenzone octisalate spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57817-300
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (OCTINOXATE) OCTINOXATE 6 g  in 100 g
    OXYBENZONE (OXYBENZONE) OXYBENZONE 4 g  in 100 g
    OCTISALATE (OCTISALATE) OCTISALATE 5 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:57817-300-01 10 g in 1 BOTTLE
    2 NDC:57817-300-02 12 g in 1 BOTTLE
    3 NDC:57817-300-03 15 g in 1 BOTTLE
    4 NDC:57817-300-04 20 g in 1 BOTTLE
    5 NDC:57817-300-05 25 g in 1 BOTTLE
    6 NDC:57817-300-06 30 g in 1 BOTTLE
    7 NDC:57817-300-07 35 g in 1 BOTTLE
    8 NDC:57817-300-08 40 g in 1 BOTTLE
    9 NDC:57817-300-09 45 g in 1 BOTTLE
    10 NDC:57817-300-10 50 g in 1 BOTTLE
    11 NDC:57817-300-11 60 g in 1 BOTTLE
    12 NDC:57817-300-12 70 g in 1 BOTTLE
    13 NDC:57817-300-13 80 g in 1 BOTTLE
    14 NDC:57817-300-14 90 g in 1 BOTTLE
    15 NDC:57817-300-15 100 g in 1 BOTTLE
    16 NDC:57817-300-16 110 g in 1 BOTTLE
    17 NDC:57817-300-17 120 g in 1 BOTTLE
    18 NDC:57817-300-18 150 g in 1 BOTTLE
    19 NDC:57817-300-19 180 g in 1 BOTTLE
    20 NDC:57817-300-20 200 g in 1 BOTTLE
    21 NDC:57817-300-21 250 g in 1 BOTTLE
    22 NDC:57817-300-22 300 g in 1 BOTTLE
    23 NDC:57817-300-23 2 g in 1 PACKAGE
    24 NDC:57817-300-23 2 g in 1 PACKAGE
    25 NDC:57817-300-24 3 g in 1 PACKAGE
    26 NDC:57817-300-25 4 g in 1 PACKAGE
    27 NDC:57817-300-26 5 g in 1 PACKAGE
    28 NDC:57817-300-27 6 g in 1 PACKAGE
    29 NDC:57817-300-28 7 g in 1 PACKAGE
    30 NDC:57817-300-29 8 g in 1 PACKAGE
    31 NDC:57817-300-30 9 g in 1 PACKAGE
    32 NDC:57817-300-31 10 g in 1 PACKAGE
    33 NDC:57817-300-32 12 g in 1 PACKAGE
    34 NDC:57817-300-33 15 g in 1 PACKAGE
    35 NDC:57817-300-34 20 g in 1 PACKAGE
    36 NDC:57817-300-35 25 g in 1 PACKAGE
    37 NDC:57817-300-36 30 g in 1 PACKAGE
    38 NDC:57817-300-37 35 g in 1 PACKAGE
    39 NDC:57817-300-38 40 g in 1 PACKAGE
    40 NDC:57817-300-39 45 g in 1 PACKAGE
    41 NDC:57817-300-40 50 g in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 04/18/2013
    Labeler - Hangzhou Haorun Technology CO.,LTD. (421308583)
    Establishment
    Name Address ID/FEI Business Operations
    Hangzhou Haorun Technology CO.,LTD. 421308583 manufacture(57817-300)
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