Summer Gelee Spf-4 Gel
FDA Label NDC 84281-476

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Summer Gelee Llc for the product Summer Gelee Spf-4 (NDC 84281-476). 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 ingredients, purpose, uses:, warnings:, do not use, when using this product, stop use and ask a 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 Ingredients

Homosalate 2.00%, Octisalate 2.00%

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 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 A Doctor If

  • rash or irritation develops and lasts.

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 2 hours. 
  • Use a water-resistant sunscreen if swimming or sweating.
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 10am-2pm.
  • Wear long-sleeved shirts, pants, hats, & sunglasses.

Other Information:

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

Inactive Ingredients:

Cinnamomum Cassia Oil, Hydrogenated Vegetable Oil, Iron Oxides (CI 77492), Isopropyl Myristate, Mineral Oil, Ozokerite Wax, Paraffin, Parfum (Fragrance), Petrolatum, Tocopheryl Acetate (Vitamin E), D&C Red #17.

Package Labeling:

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