Ck One Waterfresh Face Makeup Spf 15
FDA Label NDC 66184-445

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Coty Us Llc for the product Ck One Waterfresh Face Makeup Spf 15 (NDC 66184-445). 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

Octinoxate 2.5%

Titanium dioxide 5.0%

Otc - Purpose

Sunscreen

Otc - Keep Out Of Reach Of Children

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

Indications & Usage

Helps prevent sunburn

Warnings

Skin cancer/Skin Aging Alert: Spending time int he 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

For sunscreen use:


  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Children under 6 months: ask a doctor

Inactive Ingredient

aqua/water/eau, hydogentated polyisobutene, isohexadecane, dextrin palmitate, butylene glycol, hydrogenated lecithin, alcohol, triethylhexanoin, quaternium-90, bentonite, pentylene glycol, glycerin, peg-15/lauryl dimethicone crosspolymer, stearoyl inulin, phenoxyethanol, isopropl titanium triisostearate, octyldodectl pca, lysine, isododecane, dipropylene glycol, magnesium chloride, sodium chloride, sodium citrate, may contain: iron oxides, titanium dioxide, mica.

Package Label.Principal Display Panel

Waterfresh_product (Waterfresh Product)

Waterfresh_product (Waterfresh Product)

Baselabel_fair (Baselabel Fair)

Baselabel_fair (Baselabel Fair)

Waterfresh_carton (Waterfresh Carton)

Waterfresh_carton (Waterfresh Carton)

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