Sharx - Sunbreaker Moisturizing Sunscreen Spf55 Broad Spectrum
FDA Label NDC 66163-2613

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosmetic Solutions Llc for the product Sharx - Sunbreaker Moisturizing Sunscreen Spf55 Broad Spectrum (NDC 66163-2613). 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, active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

DRUG FACTS:

Active Ingredients

Octinoxate 7.5%

Zinc Oxide 4.8%

Purpose

Sunscreen

Uses

Help 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 or irritation 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 and evenly 15 minutes before sun exposure.

For children under 6 months of age: Ask a doctor.

Reapply:
At least 80 minutes after swimming or sweating, immediately after towel drying, at least every 2 hours.

  • 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 of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses.

Inactive Ingredients

Water, Hydrogenated Polybutene, Octyl Stearate, Polyglyceryl-4-Isostearate, Aloe Barbadensis Leaf Extract, Isopropyl Palmitate, Cyclomethicone, Sunflower Oil, Hydrogenated Microcrystalline Wax, Cetyl Dimethicone Copolyol, Cetyl Dimethicone, Hydrogenated Castor Oil, Sodium Chloride, Polyglyceryl-3-Oleate, Silica, Hexyl Laurate, Triethoxycaprylylsilane, Capryly Glycol, Methylisothiazolinone.

Other Information

Store at controlled temperature 15C – 30C (59F-86F). Protect the product in this container from excessive heat and direct sun.

Principal Display Panel - 60 Ml Tube Label

SHARX

SUNBREAKER
MOISTURIZER
Sunscreen SPF55
Broad Spectrum

2 Fl Oz / 60mL

Principal Display Panel (60 mL Tube Label)

Principal Display Panel (60 mL Tube Label)

* Please review the disclaimer below.