Label: PURPOSE- octinoxate, octisalate and oxybenzone 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 August 19, 2020

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

View All Sections
  • Active ingredients

    Octinoxate 7.5%
    Octisalate 5%
    Oxybenzone 3%

  • Purpose

    Sunscreen

  • Use

    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 help prevent sunburn, not skin cancer or early skin aging.

    For external use only

    Do not use on damaged or broken skin

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash occurs

  • Keep out of reach of children.

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

  • Directions

    ■ apply generously and evenly 15 minutes before sun exposure

    ■ apply to all skin exposed to the sun

    ■ use a water resistant sunscreen if swimming or sweating

    ■ reapply at least every 2 hours

    ■ children under 6 months of age:

        Ask a doctor

  • Other information

    ■ protect this product from excessive heat and direct sun

    ■ may stain or damage some fabrics or surfaces

  • Inactive ingredients

    water, octyldodecyl neopentanoate, glycerin, emulsifying wax NF, glyceryl stearate, PEG-100 stearate, dimethicone, triethanolamine, diazolidinyl urea, carbomer, methylparaben, ethylparaben, propylparaben, bisabolol, farnesol, citric acid

  • Questions/comments?

    1-800-321-4576

  • Package/Label Principal Display Panel – 118 ml Carton

    PURPOSE®

    Dual Treatment
    Moisture Lotion

    Sunscreen
    SPF 10

    Oil-Free

    Fragrance Free

    Provides

    Long-Lasting

    Moisture

    Developed with

    Dermatologists

    4 FL. OZ. (118 mL)

    4ozcarton
  • INGREDIENTS AND APPEARANCE
    PURPOSE 
    octinoxate, octisalate and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-5500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate76 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Octyldodecyl Neopentanoate (UNII: X8725R883T)  
    Glycerin (UNII: PDC6A3C0OX)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Trolamine (UNII: 9O3K93S3TK)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Ethylparaben (UNII: 14255EXE39)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Levomenol (UNII: 24WE03BX2T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0187-5500-041 in 1 CARTON10/07/2013
    1118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/07/2013
    Labeler - Bausch Health US LLC (831922468)
    Establishment
    NameAddressID/FEIBusiness Operations
    KIK Custom Product - Rexdale Plant243547333MANUFACTURE(0187-5500)
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!