Label: FOR MEN MACA ROOT ENERGETIC FACE PROTECTOR SPF 15- octisalate, avobenzone, octinoxate, and octocrylene lotion

  • NDC Code(s): 57691-298-10
  • Packager: Buth-Na-Bodhaige, 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 October 10, 2016

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients:Purpose
    Avobenzone 3.0% (w/w),Sunscreen
    Octinoxate 2.9% (w/w),Sunscreen
    Octisalate 5.0% (w/w),Sunscreen
    Octocrylene 2.2% (w/w).Sunscreen
  • Uses

    • 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 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.
    • 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 value of 15 or higher and other sun protection measures including:
      • limit time in sun especially from 10 a.m. – 2 p.m.
      • wear long-sleeved shirts, pants, hats and sunglasses.
    • reapply this product at least every 2 hours.
    • use water resistant sunscreen if swimming or sweating.
    • children under 6 months of age: ask a doctor.
  • Other information

    • protect the product in this container from excessive heat and direct sun.
  • INACTIVE INGREDIENTS

    Water, C12-15 Alkyl Benzoate, Glyceryl Stearate, Isononyl Isononanoate, Glycerin, Butylene Glycol, Sorbitol, Cetearyl Alcohol, Potassium Cetyl Phosphate, Phenoxyethanol, Caprylyl Glycol, Bertholletia Excelsa Seed Oil, Fragrance, Creatine, Xanthan Gum, Carbomer, Potassium Sorbate, Tetrasodium EDTA, Sodium Hydroxide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Hydrolyzed Lepidium Meyenii Root, 1,2-Hexanediol, Aloe Barbadensis Leaf Juice, BHT, Capryloyl Glycine, Citric Acid.

  • QUESTIONS

    To report serious side effects associated with use of the product call 1-800-263-9746.

  • PRINCIPAL DISPLAY PANEL - 100 mL Tube Label

    BROAD SPECTRUM SPF 15 SUNSCREEN

    THE
    BODY
    SHOP®

    FOR MEN
    MACA ROOT
    ENERGETIC
    FACE PROTECTOR
    SPF 15

    MOISTURISES and helps skin feel
    smoother and protected, enriched
    with Peruvian maca root.

    100 mL (3.3 US FL OZ)

    Principal Display Panel - 100 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    FOR MEN MACA ROOT ENERGETIC FACE PROTECTOR SPF 15 
    octisalate, avobenzone, octinoxate, and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57691-298
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.05 g  in 1 mL
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.03 g  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.029 g  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.022 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Isononyl Isononanoate (UNII: S4V5BS6GCX)  
    Glycerin (UNII: PDC6A3C0OX)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Sorbitol (UNII: 506T60A25R)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Brazil Nut Oil (UNII: 0G89T29HO6)  
    Creatine (UNII: MU72812GK0)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    HYDROLYSED LEPIDIUM MEYENII ROOT (ENZYMATIC) (UNII: P2799BF6GS)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Capryloyl Glycine (UNII: 8TY5YO42NJ)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57691-298-10100 mL in 1 TUBE; Type 0: Not a Combination Product03/14/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35203/14/2016
    Labeler - Buth-Na-Bodhaige, Inc., (791071279)