CVS HEALTH ULTRA PROTECTION SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [CVS PHARMACY]

CVS HEALTH ULTRA PROTECTION SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [CVS PHARMACY]
PDF | XML

NDC 69842-101-05
Set ID 7d2b008e-74c6-4431-aa55-e5f38fb7047d
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients

    Avobenzone 3.0%, Homosalate 13.0%, Octisalate 5.0%, Octocrylene 7.0%, Oxybenzone 4.0%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see ​Directions​), decreases the risk of skin cancer and early skin aging caused by the sun
  • Warnings

    ​For external use only

  • DO NOT USE

    ​Do not use

    • ​​on damaged or broken skin

  • WHEN USING

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

  • STOP USE

    ​Stop use and ask doctor if

    • rash occurs.
  • KEEP OUT OF REACH OF CHILDREN

    ​Keep out of reach of children. ​If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure

    • reapply:

    • after 80 minutes of swimming or sweating

    • immediately after towel drying

    • at least every 2 hours

    Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:

    • limit time in the sun, especially from 10 a.m. - 2 p.m.

    • wear long-sleeve shirts, pants, hats, and sunglasses

    • children under 6 months: ask a doctor

  • Other information

    • protect this product from excessive heat and direct sun
    • may stain or damage some fabrics, materials or surfaces

  • Inactive ingredients

    Water, Sorbitol, Aluminum Starch Octenylsuccinate, VP/Eicosene Copolymer, Stearic Acid, Triethanolamine, Sorbitan Isostearate, Benzyl Alcohol, Dimethicone, Tocopherol (Vitamin E), Polyglyceryl-3 Distearate, Fragrance, Methylparaben, Carbomer, Propylparaben, Disodium EDTA

  • Questions or comments?

    Call toll free 1-800-SHOP-CVS

  • PRINCIPAL DISPLAY PANEL

    CVS Health

    Ultra Protection

    Sun Lotion

    SPF 50

    BROAD SPECTRUM SPF 50 SUNSCREEN

    UVA/UVB protection

    • Hypoallergenic
    • Non-greasy
    • Water resistant (80 minutes)
    • Dermatologist tested

    COMPARE TO COPPERTONE®
    ultraGUARD® SPF 50 LOTION*
    8 FL OZ (237 mL)

    Representative Image

  • INGREDIENTS AND APPEARANCE
    CVS HEALTH  ULTRA PROTECTION SPF 50
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE70 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE130 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-101-05237 mL in 1 BOTTLE; Type 0: Not a Combination Product01/09/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/09/2017
    Labeler - CVS Pharmacy (062312574)
    Registrant - Fruit of the Earth, Inc. (079559467)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(69842-101)

Related Drugs