For Men Maca Root Energetic Face Protector Spf 15
FDA Label NDC 57691-298

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Buth-na-bodhaige, Inc., for the product For Men Maca Root Energetic Face Protector Spf 15 (NDC 57691-298). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

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.

Otc - Do Not Use

Do not use

  • on damaged or broken skin.

Otc - When Using

When using this product

  • Keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if

  • rash occurs.

Otc - Keep Out Of Reach Of Children

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.

Otc - 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)

Principal Display Panel (100 mL Tube Label)

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