Totally Fun After Sun Gel
FDA Label NDC 72085-145

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mj Products Association, Llc for the product Totally Fun After Sun (NDC 72085-145). 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, indications, warnings, do not use, stop use and ask a doctor, 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

Drug Facts

Active Ingredients

Lidocaine HCL 1.50%

Purpose

Topical Anesthetic

Indications

For the Temporary relief of pain and itching due to sunburn, minor skin irritations, minor cuts, minor burns, scrapes and insect bites.

Warnings

FOR EXTERNAL USE ONLY

Do Not Use

  • in large quantites, particularly over raw or blistered areas.
  • Avoid contact with eyes.

Stop Use And Ask A Doctor

  • if condition gets worse, symptoms last for more than 7 days, or symptoms clear up and occur again with a few days.
  • If sumptoms persist for more than seven days, discontinue use and consult physician.

Keep Out Of Reach Of Children.

If swallowed, consult physician.

Directions

  • Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.
  • Children under two-years of age: consult a physician.

Additional Information

Store at room temperature.

Other Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Carbomer, Ethylhexylglycerin, Glitter: Polyethylene Terephthalate, Polymethyl Methacrylate, Polyurethan-33, FD&C Yellow #5, D&C Red #7; Parfum (Orange Fragrance), Phenoxyethanol, Terephthalate, Triethanolamine.

Questions Or Comments?

Contact us directly at 1-888-601-0441

Distr. by/par: Sunshine & Glitter

MJ Products Association LLC

9750 NW 17th Street,  Miami, FL 33172

www.sunshineglitter.com

All Rights Reserved.

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