Otc - Active Ingredient
Active Ingredient ........ Purpose
Octinoxate 7.5% ........ Sunscreen
Octocrylene 8% ........ Sunscreen
Oxybenzone 3% ........ Sunscreen
Titanium Dioxide 5% ........ Sunscreen
Exel Clarifying Line Cream
FDA Label NDC 53863-125
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Exelencia Importers for the product Exel Clarifying Line (NDC 53863-125). 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 and precautions, 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.
Label Section Quick Index
Otc - Purpose
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
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.
Indications & Usage
Stop use and ask a doctor if rash occurs
Warnings And Precautions
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.
Dosage & Administration
Directions
- Apply liberally 15 minutes before sun exposure
- Reapply at least every 2 hours
- Children under 6 month: ask a doctor
-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 PMWear long-sleeved shirts, pants, hats, and sunglassesUse a water resistant sunscreen if swimming or sweating
Inactive Ingredient
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, BHT, Butyrospermum Parkii (shea butter) Extract, Calcium Disodium EDTA, Caprylic/Capric Triglyceride, Cetearyl Alcohol (and) Ceteareth-20, Cyclomethicone, Cyclopentasiloxane, Diethlyamino Hydroxybenzoyl Hexyl Benzoate, Dimethicone, DMDM Hydantoin, Ectoin, Fragrance (Parfum), Glyceryl Stearate SE, Hamamelis Virginiana (witch hazel) Extract, Iron Oxides (C.I. 77497/77492/77499), Phenoxyethanol, Polysorbate 20, Propylene Glycol, Sodium DNA, Tocopheryl Acetate, Water (Aqua), Xanthan Gum, Yeast Extract (saccharomyces cerevisiae extract)
Package Label.Principal Display Panel
Exel Clarifying Line
SPF 50
Broad Spectrum SPF 50
3.30 fl.oz / 100 ml
Pa-0687-ensp-0720 (Pa 0867 Ensp 0720)
Pm-0867-ensp-0720a (Pm 0867 Ensp 0720a)
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