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DRUG FACTS:
The following Structured Product Label (SPL) was submitted to the FDA by Cosmetic Solutions Llc for the product Aldana Skin Life - Sunscreen Broad Spectrum Spf 55 Water Resistant (80 Mins.) (NDC 66163-5500). 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 other, active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
DRUG FACTS:
Octinoxate 7.5%, Zinc Oxide 4.8%
Sunscreen
Helps prevent sunburn.
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.
Apply liberally and evenly 15 minutes before sun exposure.
For children under 6 months of age: Ask a doctor.
Reapply: At least 80 minutes after 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:Water, Hydrogenated Polybutene, Octyl Stearate, Polyglyceryl-4-Isostearate, Aloe Barbadensis Leaf Extract, Isopropyl Palmitate, Cyclomethicone, Sunflower Oil, Hydrogenated Microcrystalline Wax, Cetyl Dimethicone Copolyol, Cetyl Dimethicone, Hydrogenated Castor Oil, Sodium Chloride, Polyglyceryl-3-Oleate, Silica, Hexyl Laurate, Triethoxycaprylylsilane, Capryly Glycol, Methylisothiazolinone.
Protect the product in this container from excessive heat and direct sun.
* Please review the disclaimer below.