The following Structured Product Label (SPL) was submitted to the FDA by Exelencia Importers Corp for the product Sunscreen Creme Spf 37 (NDC 53863-120). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Sunscreen Ingredients
Octocrylene (sunscreen) 5,0%
Octinoxate (Ethylhexyl Methoxy cinnamate) (sunscreen) 7,5%
Octisalate (Ethylhexyl Salicylate) (sunscreen) 5,0%
Oxybezone (Benzophenone 3) (sunscreen) 3,0%
Titanium Dioxide (sunscreen) 3,0%
Action:
recommend for use in exfoliating treatments with hydroxy acids during summer and, perticularly, when Exel's "Skin Renewal Micro Peel System" is applied.
Helps prevent sunburn
Ultra moisturizing action. Enhanced with Aloe Vera gel, Shea Butter and Vitamin E Acetate.
Dermatologically tested. It does not contain PABA (4-Aminobenzoic Acid).
Keep out of reach of children.
Stop use if and ask a doctor if rash occurs. If swallowed get medical help or contact a poison control center right away.
External use only.
Do not use in on damaged or broken skin.
Contains Oxybenzone.
When using this product, keep out of eyes.
Skin cancer/ Skin aging alert:
Spending time in the sun increases your risk of skin cancer and early skin aging.
This product has been shown only to prevent sunburn and not skin cancer and early skin aging.
Limit time in the sun 10 am to 2 p (North Hemisphere).
Wear long-sleeve shirts, pants, hats and sunglasses.
Children should avoid prolonged exposure to sunlight.
Sunscreens do not prevent heat stroke.
Product only available through a professional.
How to use
No water resistant product: Apply Liberally 15 minutes before sun exposure.
Reapply at least every two hours. Apply generously before exposure to sun as much as needed. Apply again every 2 hours or immediately after having a bath, energetic activity, excessive perspiration or when using a towel to maintain product effectiveness.
Children under 6 months: ask a doctor.
Protect this product from excessive heat and sunlight.
INCI Inactive Ingredients
Deionized Water (aqua) * Propylene Glycol * Glycerin * Glyceryl Stearate * Cetyl Alcohol * Stearic Acid * Dimethicone * Aloe Barbadensis (Leaf Extract) * Hamamelis Liquid Extract (Hamamelis Virginiana Extract) * Polysorbate 20 * DMDM Hydantoin
* Methylparaben * propylparaben * Iron Oxides (CI:77.491, CI:77.492, CI 77.499) * Acrylates/C10-30 Alkyl Acrylate Crosspolymer * Shea butter (Butyrospermum Parkii Butter) * Xanthan Gum * Tocopheryl Acetate (vitamin E acetate) * Triethanolamine
* Fragrance (Parfum) * BHT.
Image Of Carton Label (Carton)
Image Of Bottle Label (Bottle)
Exel
Sun Protection Creme SPF
contains Vitamin E Acetate, Shea Butter, and Aloe Vera Gel.
1.69 fl. oz 50
* Please review the disclaimer below.
