Sun Protection Creme Spf 30 Plus
FDA Label NDC 53863-122

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Exelencia Importers Corp for the product Sun Protection Creme Spf 30 Plus (NDC 53863-122). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients           Purpose

Octocrylene 5%             Sunscreen

Octinoxate 7.5%            Sunscreen

Octisalate 5%                Sunscreen

Oxybenzone 3%            Sunscreen

Titanium Dioxide 3%      Sunscreen             

Otc - Purpose

Uses

  • Helps Prevent Sunburn

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.

Indications & Usage

Stop use and ask a doctor if rash occurs

Warnings

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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

Dosage & Administration

Directions

  • Apply liberally 15 minutes before sun exposure
  • Reapply:
  • At least every 2 hours
  • Children under 6 months ask doctor

Inactive Ingredient

WATER, PROPYLENE GLYCOL, GLYCERIN, GLYCERYL STEARATE, CETYL ALCOHOL, STEARIC ACID, DIMETHICONE, ALOE VERA LEAF, HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT, POLYSORBATE-20, DMDM HYDANTOIN, METHYLPARABEN, PROPYLPARABEN, IRON OXIDE CI 77491, CI 77492, CI 77499, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, SHEA BUTTER, XANTHAN GUM, TOCOPHERYL ACETATE, TRIETHANOLAMINE, FRAGRANCE, BHT

Package Label.Principal Display Panel

Exel Clarifying Line

High Sun Protection Creme
SPF 30 PLUS

for use in "Exel Clarifying program"

3.30 fl. oz

Box (Skmbt C35141208165400)

Box (Skmbt C35141208165400)

* Please review the disclaimer below.