Active Ingredients
Titanium Dioxide 5.00%
Zinc Oxide 5.00%
Rae Climate Control Moisturizing Mineral Tint 65% Cream
FDA Label NDC 84645-178
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rae Cosmetics for the product Rae Climate Control Moisturizing Mineral Tint 65% (NDC 84645-178). 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, purpose, use, warnings, directions, other information, indications & usage, recent major changes, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen active
Use
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.
Directions
Apply liberally 15 minutes before sun exposure.
Use water resistant sunscreen if swimming or sweating.
Reapply at least every 2 hours.
Children under 6 months: ask a doctor.
Sun Protection Measures: Spending time in the sun increases risk of skin cancer and early 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 10:00 am - 2:00 pm. Wear long sleeved shirts, pants, hats and sunglasses.
Other Information
Protect this product from exessive heat and direct sun.
Indications & Usage
Stop use and ask a doctor if rash occurs.
Recent Major Changes
dosage & admin update
Inactive Ingredient
Water, Cyclopentasiloxane, Butylene Glycol, Titanium Dioxide, Zinc Oxide, Octyldodecyl Neopentanoate, PEG/PPG-18/18 Dimethicone, Dimethicone, Tocopherol, Tetrahexyldecyl Ascorbate, Retinyl Palmitate, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Ginkgo Biloba Leaf Extract, Panax Ginseng Root Extract, Octyldodecanol, Boron Nitride, Dextrin Palmitate, Palmitic Acid, Methicone, Stearic Acid, Magnesium Chloride, Potassium Chloride, Sodium Chloride, Zinc Chloride, Magnesium Ascorbyl Phosphate, Sodium Hyaluronate, Phytantriol, Glycerin, Triethoxycaprylylsilane, Lysine, Aluminum Hydroxide, Disodium EDTA, Hexylene Glycol, Potassium Sorbate, Sodium Dehydroacetate, Caprylyl Glycol, Phenoxyethanol
MAY CONTAIN (+/-):
Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Principal Display Panel
Product-tube (25.jpg)
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