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  5. Label Information: Brighten Lightening

FDA Label for Brighten Lightening

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. OTC - ASK DOCTOR
    10. DOSAGE & ADMINISTRATION
    11. OTHER SAFETY INFORMATION
    12. INACTIVE INGREDIENT
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Brighten Lightening Product Label

The following document was submitted to the FDA by the labeler of this product Cen Beauty Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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