Brighten
FDA Label NDC 54272-301

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cen Beauty Llc for the product Brighten (NDC 54272-301). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - 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

Otc - Active Ingredient

ACTIVE INGREDIENT

ZINC OXIDE 15%

OCTINOXATE 6%

Otc - Purpose

PURPOSE

SUNSCREEN

Indications & Usage

USES

  • Lightens discolored skin such as freckles, age and liver spots or pigment in the skin that may occur from pregnancy or from the use of oral contraceptives

Warnings

WARNINGS

FOR EXTERNAL USE ONLY

Otc - Do Not Use

DO NOT USE

  • IF YOU HAVE VERY SENSITIVE SKIN

Otc - When Using

WHEN USING THIS PRODUCT

  • Keep out of eyes. Rinse with water to remove.

Otc - Stop Use

STOP USE AND ASK A DOCTOR IF RASH OCCURS.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Otc - Ask Doctor

ASK A DOCTOR BEFORE USE

  • On children under 12 years of age
  • If you are pregnant, breastfeeding or intend to become pregnant within 3 months of use.

Dosage & Administration

DIRECTIONS

  • Apply a thin layer on affected area twice daily or as directed by a doctor.
  • If no improvement is seen after 3 months treatment, discontinue use.
  • Lightening effect may not be noticeable when used on very dark skin.
  • Limit sun exposure during and after use to prevent darkening from reoccurring.
  • Use a sun blocking agent or protective clothing. This product is not for use in the prevention of sunburn.
  • Consult your physician before use.

Other Safety Information

Other Information

  • STORE AT 15-30°C (59-86°F)
  • PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

Inactive Ingredient

INGREDIENTS

aqua (water), cyclopentasiloxane, PEG-10 dimethicone, dimethicone, butylene glycol, cyclohexasiloxane, glycerin, carollina officinalis extract, algae extract, avena sativa (oat) kernel extract, angelica sinensis extract, 10-hydroxydecanoic acid, sebacic acid, 1,10-decanediol acid, betaine, dimethicone/vinyl dimethicone crosspolymer, lauryl PEG-9 polydimethylsiloxyethyl dimethicone, lecithin, dimethicone/PEG-10/15 crosspolymer, triethoxycaprylylsilane, decamethylcyclopentasiloxane, trifluoromethyl C1-C4 alkyl dimethicone, quaternium-90, bentonite, butylene glycol, sodium chloride, sodium citrate, ethylhexylglycerin, propylene carbonate, propylene glycol, potassium sorbate, methylisothiazolinone, iodopropynyl butylcarbamate, phenoxyethanol

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