FDA Label for Ultra Replenishing Sunscreen Spf 40
View Indications, Usage & Precautions
Ultra Replenishing Sunscreen Spf 40 Product Label
The following document was submitted to the FDA by the labeler of this product Cosmedical Technologies, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Homosalate 8%
Octisalate 5%
Octocrylene 5%
Zinc Oxide 8%
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
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