Active Ingredients (% W/W)
Avobenzone 2.5%
Octinoxate 3%
Octisalate 3%
Titanium Dioxide 1.25%
Dermacinrx Skin Moisturizing Ultra Spf 50 Sunscreen Lotion
FDA Label NDC 59088-568
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Puretek Corporation for the product Dermacinrx Skin Moisturizing Ultra Spf 50 Sunscreen (NDC 59088-568). 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 active ingredients (% w/w), purposes, uses, warnings, do not use, when using this product, stop use and ask a doctor if, 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
Purposes
Sunscreen (Avobenzone 2.5%)
Sunscreen (Octinoxate 3%)
Sunscreen (Octisalate 3%)
Sunscreen (Titanium Dioxide 1.25%)
Uses
■ Helps prevent sunburn.
■ If used as a directed with other sun protection measures (see Directions), decreases the risk of cancer and early skin aging caused by the sun.
Warnings
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
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.
Directions
■ Apply liberally 15 minutes before sun exposure ■ Use a water-resistant sunscreen if swimming or sweating or immediately after towel drying
■ Reaply: ■ 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 the 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, especially from 10 a.m. - 2 p.m. ■ Wear long-sleeve shirts, pants, hats, and sunglasses. ■ Children under six months of age: Ask a doctor.
Inactive Ingredients
Water, Emulsifying Wax, Shea butter, Stearic Acid, Ethylhexyl Palmitate, Phenoxyethanol, Benzoic Acid, Dehydroacetic Acid, Sunflower Seed Oil, Isopropyl Isostearate, Vitamin E, Potassium Sorbate, Xanthan Gum, Sodium Benzoate.
Other Information
■ Protect this product from excessive heat and direct sun
Questions?
1.800.611.4270
Dermacin ®Rx Skin Moisturizing Ultra Spf 50 Sunscreen Lotion (Label)
DISTRIBUTED BY:
PureTek Corporation
San Fernando, CA 91340
Image Description (Label)
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