Label: SPF 30 SUNSCREEN- octinoxate oxybenzone octisalate spray

  • Contains inactivated NDC Code(s)
    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

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 March 30, 2013

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active Ingredient

    Octinoxate 6.0%

    Oxybenzone 4.0%

    Octisalate 5.0%

    sunscreen

  • Use

    Protection from the sun’s damaging effects.

  • 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.

  • 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.

  • Inactive Ingredient

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

  • PRINCIPAL DISPLAY PANEL

    label of sunscreen
  • INGREDIENTS AND APPEARANCE
    SPF 30 SUNSCREEN 
    octinoxate oxybenzone octisalate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57817-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    Glycerin (UNII: PDC6A3C0OX)  
    Tocopherol (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57817-300-0110 g in 1 BOTTLE
    2NDC:57817-300-0212 g in 1 BOTTLE
    3NDC:57817-300-0315 g in 1 BOTTLE
    4NDC:57817-300-0420 g in 1 BOTTLE
    5NDC:57817-300-0525 g in 1 BOTTLE
    6NDC:57817-300-0630 g in 1 BOTTLE
    7NDC:57817-300-0735 g in 1 BOTTLE
    8NDC:57817-300-0840 g in 1 BOTTLE
    9NDC:57817-300-0945 g in 1 BOTTLE
    10NDC:57817-300-1050 g in 1 BOTTLE
    11NDC:57817-300-1160 g in 1 BOTTLE
    12NDC:57817-300-1270 g in 1 BOTTLE
    13NDC:57817-300-1380 g in 1 BOTTLE
    14NDC:57817-300-1490 g in 1 BOTTLE
    15NDC:57817-300-15100 g in 1 BOTTLE
    16NDC:57817-300-16110 g in 1 BOTTLE
    17NDC:57817-300-17120 g in 1 BOTTLE
    18NDC:57817-300-18150 g in 1 BOTTLE
    19NDC:57817-300-19180 g in 1 BOTTLE
    20NDC:57817-300-20200 g in 1 BOTTLE
    21NDC:57817-300-21250 g in 1 BOTTLE
    22NDC:57817-300-22300 g in 1 BOTTLE
    23NDC:57817-300-232 g in 1 PACKAGE
    24NDC:57817-300-232 g in 1 PACKAGE
    25NDC:57817-300-243 g in 1 PACKAGE
    26NDC:57817-300-254 g in 1 PACKAGE
    27NDC:57817-300-265 g in 1 PACKAGE
    28NDC:57817-300-276 g in 1 PACKAGE
    29NDC:57817-300-287 g in 1 PACKAGE
    30NDC:57817-300-298 g in 1 PACKAGE
    31NDC:57817-300-309 g in 1 PACKAGE
    32NDC:57817-300-3110 g in 1 PACKAGE
    33NDC:57817-300-3212 g in 1 PACKAGE
    34NDC:57817-300-3315 g in 1 PACKAGE
    35NDC:57817-300-3420 g in 1 PACKAGE
    36NDC:57817-300-3525 g in 1 PACKAGE
    37NDC:57817-300-3630 g in 1 PACKAGE
    38NDC:57817-300-3735 g in 1 PACKAGE
    39NDC:57817-300-3840 g in 1 PACKAGE
    40NDC:57817-300-3945 g in 1 PACKAGE
    41NDC:57817-300-4050 g in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/18/2013
    Labeler - Hangzhou Haorun Technology CO.,LTD. (421308583)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hangzhou Haorun Technology CO.,LTD. 421308583manufacture(57817-300)