Otc - Active Ingredient
Homosalate 8%
Octisalate 5%
Octocrylene 5%
Zinc Oxide 8%
Ultra Replenishing Sunscreen Spf 40 Cream
FDA Label NDC 70060-1901
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmedical Technologies, Llc for the product Ultra Replenishing Sunscreen Spf 40 (NDC 70060-1901). 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, inactive ingredient, warnings and precautions, dosage & administration, 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 - Purpose
Sunscreen
Inactive Ingredient
Water
C12-15 Alkyl Benzoate
Glycerin
Mica
Polyglyceryl-2 Stearate
Glyceryl Stearate
Steareth-21
Stearyl Alcohol
Dimethicone
Phenoxyethanol
Simmondsia Chinensis (Jojoba) Seed Oil
Steareth-2
Fructose
Cocos Nucifera (Coconut) Oil
Citric Acid
Ethylhexylglycerin
Hydroxyethylcellulose
Chlorphenesin
Hydrolyzed Rice Protein
Titanium Dioxide (CI 77891)
Tocopheryl Acetate
Kaempferia Galanga Root Extract
Aloe Barbadensis Leaf Juice
Sodium Phytate
Lavandula Angustifolia (Lavender) Oil
Withania Somnifera Flower Extract
Iron Oxide (CI 77492)
Iron Oxide (CI 77491)
Citrus Aurantium Dulcis (Orange) Peel Oil
Silica
Dimethylmethoxy Chromanol
Vanilla Planifolia Fruit Extract
Iron Oxide (CI 77499)
Warnings And Precautions
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 swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
• Apply liberally and evenly 15 minutes before sun exposure.
• Reapply: at least every 2 hours
• Use a water-resistant sunscreen if swimming or sweating.
• 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 Broad Spectrum SPF value 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-sleeved shirts, pants, hats and sunglasses • Children under 6 months of age: Ask a doctor.
Package Label.Principal Display Panel
Ultrarep50 (Ultrarep50)
* Please review the disclaimer below.
