SURFACE SUN ACTIVE DEFENSE SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [SURFACE PRODUCTS CORP]

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  • SURFACE SUN ACTIVE DEFENSE SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [SURFACE PRODUCTS CORP]

SURFACE SUN ACTIVE DEFENSE SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [SURFACE PRODUCTS CORP]
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NDC 72344-007-06
Set ID 6d0d1b1f-eaf7-603c-e053-2a91aa0ad307
Category HUMAN OTC DRUG LABEL
Packager Surface Products Corp
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active Ingredients

    Avobenzone 2%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%

  • Purpose

    Sunscreen

  • Use

    Helps prevent sunburn.

  • Warnings

    For external use only.

    Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes 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 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-sleeved shirts, pants, hats, and sunglasses.

    Children under 6 months: ask a doctor.

  • Inactive Ingredients

    Water, Propylene Glycol, Neopentyl Glycol Diheptanoate, Polyamide-8, Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzyl Alcohol, Chlorphenesin, Disodium EDTA, Oleth-3, Triethanolamine, Fragrance.

  • Label

    Surface Sun Active Defense SPF 30

  • INGREDIENTS AND APPEARANCE
    SURFACE SUN ACTIVE DEFENSE SPF 30 SUNSCREEN 
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72344-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    OLETH-3 (UNII: BQZ26235UC)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
    POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72344-007-06177 mL in 1 TUBE; Type 0: Not a Combination Product03/14/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/14/2018
    Labeler - Surface Products Corp (010777036)
    Registrant - CGI Packaging, LLC (080691099)
    Establishment
    NameAddressID/FEIBusiness Operations
    CGI Packaging, LLC080691099manufacture(72344-007)
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