Label: SPF 50 STAY PUT SUNSCREEN- octinoxate, octisalate, oxybenzone, titanium dioxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 January 15, 2016

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

View All Sections
  • Drug Facts

  • Active ingredients:

    Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 6.0%, Titanium Dioxide 2.6%

    Purpose:

    Sunscreen

  • Uses:

    · Helps prevent sunburn.

  • Warnings:

    ​Skin Cancer/ Skin Aging Alert

    Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.​

    • ​For external use only

    Do not use

    on broken or damaged skin.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

    When using this product

    keep out of eyes. Rinse with warm water to remove.

    Stop use and ask a doctor

    if rash occurs.

  • Directions:

    · Apply liberally to cool, dry skin 15 minutes before sun exposure.
    · Use a water resistant sunscreen if swimming or sweating.
    · Reapply at least every 2 hours.
    · For children under 6 months of age: ask a doctor before using.

  • Other information:

    · Protect this product container from excessive heat and direct sun.

  • Inactive ingredients:

    Aloe Barbadensis Leaf Juice, Dicaprylyl Maleate, Neopentyl Glycol Diethylhexanoate (and) Neopentyl Glycol Diisostearate, Octyldodecyl  Neopentanoate, PEG-30 Dipolyhydroxystearate, Phenoxyethanol (and) Methyl paraben (and) Ethylparaben (and) Butylparaben (and) Propyl paraben (and) Isobutylparaben, Poly ethylene, Poly quaternium 37 (and) Propylene Glycol Dicaprylate/Dicaprate (and) PPG-1 Trideceth-6, Water

  • Package Labeling:

    OuterInner

  • INGREDIENTS AND APPEARANCE
    SPF 50 STAY PUT SUNSCREEN 
    octinoxate, octisalate, oxybenzone, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70392-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE60 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE26 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIOCTYL MALEATE (UNII: OD88G8439L)  
    NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)  
    NEOPENTYL GLYCOL DIISOSTEARATE (UNII: 4M6OQ34JWW)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2)  
    PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)  
    PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70392-014-011 in 1 CARTON
    159 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/14/2016
    Labeler - Sawyer Products (118285923)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!