Otc - Active Ingredient
Active Ingredient Purpose
Octinoxate(Ethylhexyl methoxycinnamate) 7.5% Sunscreen
Octocrylene 7.0% Sunscreen
Octisalate (Ethylhexyl salicylate) 2.0 Sunscreen
Silk Line Silk Day Cream Spf 15 Cream
FDA Label NDC 67623-610
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 Silk Line Silk Day Cream Spf 15 (NDC 67623-610). 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.
Label Section Quick Index
Otc - Purpose
Uses
Helps prevent sunburn
Higher SPF gives more sunburn protection
If used as directed with other sun-protection measures ( see Directions) decreases the risk of skin cancer and early skin aging caused by de sun
Otc - Keep Out Of Reach Of Children
Do not use in children. Keep out of reach of children.
Indications & Usage
Stop use and ask a doctor if rash occurs
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.
If product is swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- Apply and massage with a gentle circular motion in face and neck until completely absorbed 15 minutes before sun exposure.
- Reapply at least every 2 hours after towel drying, swimming or perspiring.
- Sun protection measures: spending time in the sun increases your risk of skin cancer and early skin ageing. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher or other sun protection measures including:
- Limit time in the sun, especially between 10am-2pm
- Wear long sleeved shirts, pants, hats and sunglasses
- Use a water resistant sunscreen if swimming or sweating.
Inactive Ingredient
Inactive ingredients
Purified Water (aqua), Cyclopentasiloxane, Glycerin1, Glyceryl Stearate SE, Caprylic/Capric Triglyceride, Cyclomethicone, Dimethiconol, Hydrolyzed Silk, Ceteraryl Alcohol, Ceteareth-20, Yeast Extract, Sodium DNA, Aloe Barbadensis Leaf Extract, Panthenol, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Imidazolinyl Urea, Butyrospermum Parkii Butter, Phenoxyethanol, Bisabolol, Tocopheryl Acetate, Calcium Disodium EDTA, DM DM Hydantoin, Polysorbate 20, Methylparaben, Fragrance (parfum), BHT, Propylparaben, Sodium Hyaluronate, Betacarotene
Package Label.Principal Display Panel
Exel
Silk Line
Silk Day Cream SPF 15
with hydrolyzed silk proteins
Linea Seda
Crema De Dia FPS 15
Con hydrolizado de proteinas de seda
Biocosmetica Proffesional
1,69 fl Oz 50 ml
Pa-0610-005-cl-1020 (Pa 0610 005 Ci 1020)
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