Label: FOR MEN MACA ROOT ENERGETIC FACE PROTECTOR SPF 15- octisalate, avobenzone, octinoxate, and octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 57691-298-10 - Packager: Buth-Na-Bodhaige, Inc.,
- 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 October 10, 2016
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
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Directions
- Apply liberally 15 minutes before sun exposure.
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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
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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
- PRINCIPAL DISPLAY PANEL - 100 mL Tube Label
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INGREDIENTS AND APPEARANCE
FOR MEN MACA ROOT ENERGETIC FACE PROTECTOR SPF 15
octisalate, avobenzone, octinoxate, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57691-298 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.05 g in 1 mL Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.03 g in 1 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.029 g in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 0.022 g in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57691-298-10 100 mL in 1 TUBE; Type 0: Not a Combination Product 03/14/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 03/14/2016 Labeler - Buth-Na-Bodhaige, Inc., (791071279)