Kandesn Cc Cream
FDA Label NDC 62191-213

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sunrider Manufacturing L.p. for the product Kandesn Cc Cream (NDC 62191-213). 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 - purpose, dosage & administration, otc - active ingredient, inactive ingredient, warnings, otc - keep out of reach of children, package and label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Purpose

USES:

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreased the risk of skin cancer and early skin aging caused by the sun.

Dosage & Administration

DIRECTIONS:

  • apply liberally 15 minutes before sun exposure
  • Reapply:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
    • limit time in the sun, expecially from 10 a.m. - 2 p.m.
      • wear long-sleeve shirts, pants, hats, and sunglasses
      • Children under 6 months: Ask a doctor

Otc - Active Ingredient

ACTIVE INGREDIENTS:

Titanium Dioxide 11.4%
Zinc Oxide 5.5%

Inactive Ingredient

OTHER INGREDIENTS: 

Water (Deionized)
Caprylic/Capric
Triglyceride, Octyldodecyl
Neopentanoate, VP/Eicosene Copolymer,
Squalane (Veg. Origin),
Cyclopentasiloxane, Glyceryl Stearate,
PEG-100 Stearate, Cetyl Alcohol,
Hydrogen Dimethicone, Alumina,
Glycerin, Iron Oxides, Olea Europaea
(Olive) Fruit Oil, Persea Gratissima
(Avocado) Oil, Simmondsia Chinensis
(Jojoba) Seed Oil, Tocopheryl Acetate
(Natural), Tocopherol, Lysine PCA,
Ceramide-3, Panicum Miliaceum (Millet)
Seed Extract, Ceratonia Siliqua (Carob)
Gum, Phospholipids, Ruscus Aculeatus
Root Extract (Butcherbroom), Avena
Sativa (Oat) Kernel Protein, Symphytum
Officinale Extract (Comfrey), Plantago
Ovata Seed Extract (Plantain), Hydrolyzed
Wheat Protein, Xanthan Gum,
Cyclomethicone, Triethoxycaprylylsilane,
Sodium Polyacrylate, Propylene Glycol,
Cellulose Gum, Dimethiconol, Carbomer,
Triethanolamine, Magnesium Aluminum
Silicate, Polyhydroxystearic Acid, Phenyl
Trimethicone, Hexyldecanol, Citric Acid,
Trisodium EDTA, Phenoxyethanol,
Ethylhexylglycerin, Sodium Benzoate,
and Fragrance.

Warnings

WARNINGS:

FOR EXTERNAL USE ONLY

Do not use on damaged or broken skin

When using this product keep oout of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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.

Package And Label

Carton

Carton (Box And Label Cc Cream Light Medium)

Carton (Box And Label Cc Cream Light Medium)

Label

Label (Tube Cc Cream Light Medium)

Label (Tube Cc Cream Light Medium)

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