Jess Beauty Sun Drops Sunscreen Oil Spf-50 Lotion
FDA Label NDC 83542-409

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Jess Beauty Products Llc for the product Jess Beauty Sun Drops Sunscreen Oil Spf-50 (NDC 83542-409). 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 drug facts, active ingredientes, purpose, uses, warnings, do not use, when using this product, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredientes

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 10%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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 Doctor If

rash occours.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Directions

  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply at least every two hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • Sun Protection MeasuresSpending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with 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-sleeved shirts, pants, hats, and sunglasses.

Other Information

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Adansonia Digitata (Baobab) Oil, Aloe Extract, Bis-Vinyl Dimethicone/Dimethicone Copolymer, Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Daucus Carota Sativa (Carrot) Extract, Dimethicone/Bis-isobutyl PPG-20 Crosspolymer, Isododecane, Squalane, Tocopherol (Vitamin E).

Package Labeling:

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