Label: PRIDEFUL SPF 15 LIP BALM-MELON- homosalate, octisalate, octocrylene, avobenzone stick

  • Category: HUMAN OTC DRUG LABEL

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 July 11, 2022

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  • Drug Facts

  • Active ingredients (w/w)

    Homosalate 10% Octisalate 5%

    Octocrylene 3% Avobenzone 2%

    Purpose

    Susncreen

  • Use

    Helps prevent sunburn.

  • Warnings

    For external use only.

    Do not use

    on damaged or broken skin.

    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 sunrbun, not skin cancer or early skin aging.

    When using this product

    Keep out of eyes. Rinse with water to remove.

    Stop use and ask doctor

    if rash occurs.

    Keep out of reach of children

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

  • Directions

    • Apply liberally 15 minutes before sun exposure;
    • Use a water resistant sunscreen if swimming or swimming or sweating
    • Reapply at least every 2 hours;
    • Children under 6 month: Ask a doctor.
  • Other information

    Protect this product from excessive heat and direct sunlight.

  • Inactive ingredients

    Ethylhexyl Palmitate, Mineral Oil, Polybutene, Hydroxystearic Acid, Ethylene/Propylene/Styrene Copolymer, Stearic Acid, Fragrance, Stevioside, Palmitic Acid, Tocopheryl Acetate, Simmondsia Chinensis (Jojoba) Seed Oil, Prunus, Amygdalus Dulcis (Sweet Almond) Oil, Yellow 10 Lake, Blue 1 Lake, Palmitate

  • Package Labeling:

    Label4

  • INGREDIENTS AND APPEARANCE
    PRIDEFUL SPF 15 LIP BALM-MELON 
    homosalate, octisalate, octocrylene, avobenzone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82866-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE30 mg  in 1 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    12-HYDROXYSTEARIC ACID (UNII: 933ANU3H2S)  
    ETHYLENE (UNII: 91GW059KN7)  
    PROPYLENE (UNII: AUG1H506LY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEVIOSIDE (UNII: 0YON5MXJ9P)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82866-003-003 g in 1 TUBE; Type 0: Not a Combination Product07/28/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/28/2022
    Labeler - PRIDEFUL LLC (118596264)
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