Ceile Shade Protect Broad Spectrum Spf 45 Sunscreen Caymans Cream
FDA Label NDC 83103-4200

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by L�e Cosmetics Inc for the product Ceile Shade Protect Broad Spectrum Spf 45 Sunscreen Caymans (NDC 83103-4200). 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, uses, warnings, directions, inactive ingredients, other information, questions?, purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Titanium Dioxid 6.8%

Zinc Oxide 5.85%

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
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 docor if rash occurs
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

•apply generously 15 minutes before sun exposure and as needed
• 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 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 sunglasses
• children under 6 months of age: Ask a doctor

Inactive Ingredients

Mica, Dimethicone, Boron Nitride, Synthetic Fluorphlogopite, Hydrogenated Polyisobutene, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Zinc Stearate, Diisostearyl Malate, Ethylhexylglycerin, Triethoxycaprylylsilane, Caprylyl Glycol, Aluminum Hydroxide, Tin Oxide, Tocopherol, CI 77891 (Titanium Dioxide), CI 77491, CI 77492, CI 77499 (Iron Oxides).

Other Information

Protect the product in this container from excessive heat and direct sun.

Questions?

1-866-860-0811

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