Otc - Purpose
Active ingredient Purpose
Zinc Oxide 21.1% ...... Sunscreen
Caudalie Daily Mineral Sunscreen Broad Spectrum Spf 50 Lotion
FDA Label NDC 76296-060
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Caudalie Usa, Inc. for the product Caudalie Daily Mineral Sunscreen Broad Spectrum Spf 50 (NDC 76296-060). 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 - purpose, uses, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
- helps prevent sunburn.
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings
For external use only.
Otc - Do Not Use
When using this product • keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if • rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
• Apply generously 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, regulalry use a sunscreen with a 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 singlasses.
•Children under 6 months of age: Ask a doctor.
Other Information
• Protect the product in this contaner from excessive heat and direct sun.
Inactive Ingredients
Aqua/Water/Eau, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Calcium Sodium Borosilicate, Erythritol, Lauryl Laurate, Propanediol, Carthamus Tinctorius Oleosomes, Bentonite, Niacinamide, Palmitoyl Grapevine Shoot Extract, Cetearyl Alcohol, Caprylyl Glycol, Ethyl Ferulate, Sucrose Polystearate, Helianthus Annuus (Sunflower) Seed Oil,Sucrose Stearate, Coco-Glucoside, Bisabolol, Citric Acid, Caramel, Polyhydroxystearic Acid, Pongamia Pinnata Seed Extract, Sodium Gluconate, Caprylhydroxamic Acid, Glycerin, Tocopherol, Microcrystallnine Cellulose, Beta-Sitosterol, Gluconolactone, Squalene, Xanthan Gum, Aloe Barbadensis Leaf Juice Powder, Sodium Benzoate.
Questions?
+1-866-826-1615
* Please review the disclaimer below.
