Label: IMPACT MELANOMA SPF 30- zinc oxide lotion

  • NDC Code(s): 76348-598-01
  • Packager: RENU LABORATORIES, INC.
  • 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 April 17, 2023

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  • STATEMENT OF IDENTITY

    IMPACT MELANOMA SPF 30

    sunscreen is broad spectrum, water

    resistant (80 minutes), free of parabens

    and made for all skin types

  • Active Ingredients

    Octyl Methoxy Cinnamate 7.00% Sunscreen

    Titanium Dioxide 1.25% Sunscreen

    Zinc Oxide 1.25% Sunscreen

    Octyl Salicylate 1.00% Sunscreen

  • Purpose

    Octyl Methoxy Cinnamate 7.00% Sunscreen

    Titanium Dioxide 1.25% Sunscreen

    Zinc Oxide 1.25% Sunscreen

    Octyl Salicylate 1.00% 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 on damaged or broken skin.
    • When using this product keep out of eyes. Rinse with water to remove.
    • Stop use and consult physician if irritation or rash develops.
    • Keep out of reach of children.
    • If product is swallowed, get medical attention or contact poison control center immediately.
  • DIRECTIONS

    • Apply liberally 15 minutes before sun exposure
    • Reapply after 80 minutes of swimming or sweating.
    • reapply immediately after towel drying.
    • Reapply 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 sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:
    • Limited time in the sun, especially between 10am and 2pm.
    • Wear long sleeve shirts, pants, hats and sunglasses.
    • For children under 6 months, consult a physician.
  • OTHER INGREDIENTS

    Aloe Barbadensis (Aloe Vera) Leaf Juice, Calendula Officinalis (Marigold) Flower Extract, Caprylyl Glycol, Carbopol, Ceteareth-20, Cetearyl Alcohol, Deionized Water, Dimethicone, Glycerin, Hexylene Glycol, Isocetyl Stearate, Malva Sylvestris (Mallow) Flower Extract, Panax Ginseng Root Extract, Phenoxyethanol, Polyester-7, Neopentyl Glycol, Diheptanoate, Sorbitol, Stearic Acid,

    Symphytum Officinale (Comfrey) Leaf Extract, Triethanolamine, Tocopheryl Acetate (Vitamin E)

  • Other information

    • Protect this product from excessive heat and direct sunlight.
    • May stain some fabrics.
  • Questions or Comments?

    Visit www.BrightGuard.com or call (310) 589-4116

  • PRINCIPAL DISPLAY PANEL

    Impact SPF LABEL

    LABEL FOR IMPACT MELANOMA SPF

  • INGREDIENTS AND APPEARANCE
    IMPACT MELANOMA SPF 30 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-598
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17.5 g  in 1000 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE70 g  in 1000 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE10 g  in 1000 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE12.5 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    MALVA SYLVESTRIS FLOWER (UNII: 12X9JI52BS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    SORBITOL (UNII: 506T60A25R)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CARBOMER 934 (UNII: Z135WT9208)  
    WATER (UNII: 059QF0KO0R)  
    ISOCETYL STEARATE (UNII: 3RJ7186O9W)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYESTER-7 (UNII: 0841698D2F)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-598-011000 g in 1 JUG; Type 0: Not a Combination Product04/17/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/17/2023
    Labeler - RENU LABORATORIES, INC. (945739449)
    Registrant - RENU LABORATORIES, INC. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    RENU LABORATORIES, INC.945739449manufacture(76348-598)
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