Active Ingredients , Purpose
Octocrylene 10%, sunscreen
Octinoxate 5%, sunscreen
Octisalate 5%, sunscreen
Titanium dioxide 5%, sunscreen
Ensulizole 4 %, sunscreen
Exel Clarifying Line Daily Fluid Sun Shield White Color Broad Spectrum Spf 60 Plus Cream
FDA Label NDC 67623-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Biocosmetica Exel Argentina Srl for the product Exel Clarifying Line Daily Fluid Sun Shield White Color Broad Spectrum Spf 60 Plus (NDC 67623-004). 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, uses, warnings, directions, inactive ingredients, otc - keep out of reach of children, dosage & administration, indications & usage, 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. Do not swallow.
If swallowed, get medical help or contact a Poison Control Center right away.
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 .
This product is not formulated for use in children.
Directions
Apply liberally 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
Limit time in the sun, especially from 10 AM-2 PM
Wear long-sleeved shirts, pants, hats and sunglasses.
Children under 6 months of age: ask a doctor.
Inactive Ingredients
BISABOLOL, BUTYROSPERMUM PARKII BUTTER, CALCIUM DISODIUM EDTA, CAMELLIA SINENSIS LEAF EXTRACT, CAPRYLIC/CAPRIC TRIGLYCERIDE, CAPRYLYL GLYCOL, CARBOMER, CETEARETH-20, CETEARYL ALCOHOL, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, GLYCERYL STEARATE S.E., HYDROGENATED PHOSPHATIDYLCHOLINE, LINOLEIC ACID, PALMITOYL PENTAPEPTIDE-4, PHENOXYETHANOL, PHOSPHOLIPIDS, POLYPODIUM LEUCOTOMOS LEAF EXTRACT, POLYSORBATE 20, PROPANEDIOL, SODIUM ASCORBYL PHOSPHATE, SODIUM HYALURONATE, TOCOPHERYL ACETATE, WATER (AQUA), XANTHAN GUM
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Dosage & Administration
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Indications & Usage
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Package Label.Principal Display Panel
Text (Pa 603b 010 Ci 1124)
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