FOR MEN MACA ROOT ENERGETIC FACE PROTECTOR SPF 15- octisalate, avobenzone, octinoxate, and octocrylene lotion 
Buth-Na-Bodhaige, Inc.,

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.

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For Men Maca Root Energetic Face Protector SPF 15

Drug Facts

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

Warnings

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

Other information

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.

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
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)

Revised: 10/2016
Document Id: dc681ad5-1055-4be7-a3ab-5e4471008a90
Set id: 9fa1cf9b-4b14-4fb2-8613-1273416273f4
Version: 2
Effective Time: 20161010
 
Buth-Na-Bodhaige, Inc.,