Sun Control Broad Spectrum Spf 30 Cream
FDA Label NDC 84259-475

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Skinplan.us Llc for the product Sun Control Broad Spectrum Spf 30 (NDC 84259-475). 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 7%,

Octisalate 5%,

Zinc oxide 6%

Purpose

Sunscreen

Uses

  • Helps to prevent sunburn
  • 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 A Doctor If

rash or irritation develops and last.

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 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 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.

Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Citric Acid, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isododecane, Magnesium Aluminum Silicate, Polyhydroxystearic Acid, Polysorbate-20, Punica Granatum (Pomegranate) Extract, Teprenone, Tocopherol (Vitamin E), Tridecyl Salicylate, Trimethylsiloxysilicate.

Other Information

  • Protect this product from excessive heat and direct sun.
  • May stain or damage some fabrics, materials or surfaces.

Questions Or Comments?

Call 216-245-8689

Package Labelling:

Label.jpg (Label)

Label.jpg (Label)

* Please review the disclaimer below.