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Drug Facts
Facial Skin Shield Broad Spectrum Spf50 Plus Cream
FDA Label NDC 60289-302
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ahava - Dead Sea Laboratories Ltd for the product Facial Skin Shield Broad Spectrum Spf50 Plus (NDC 60289-302). 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 other, otc - purpose, uses, warnings, otc - do not use, otc - stop use, otc - when using, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| Avobenzone 2.84% | sunscreen |
| Ensulizole 3% | sunscreen |
| Homosalate 7.3% | sunscreen |
| Octisalate 5% | sunscreen |
| Octocrylene 9.89% | sunscreen |
Uses
- helps prevent sunburn
Warnings
For External Use Only
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - Stop Use
Stop use and consult a doctor if rash or irritation develops and lasts.
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
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.
Directions
- apply liberally 15 minutes before sun exposure
- use a 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 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 a.m.-2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses.
Inactive Ingredients
Aqua (Mineral Spring Water), Carthamus Tinctorius (Safflower) Oleosomes, C15-19 Alkane, Glycerin, Propanediol, Dimethyl Capramide, Aloe Barbadensis (Aloe-Vera) Leaf Juice, Tapioca Starch, Cellulose Acetate, Coco-Caprylate/ Caprate, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Aminomethyl Propanol, PEG-40 Stearate, Phenoxyethanol, Hydrogenated Palm Glycerides, Parfum (Fragrance), Tetramethyl Acetyloctahydronaphthalenes, Geraniol, Citronellol, Illite, Disodium Cetearyl Sulfosuccinate, Sodium Hydroxide, Xanthan Gum, Gluconolactone, Chlorphenesin, Sodium Citrate, 1,2-Hexanediol, Caprylyl Glycol, Didecyldimonium Chloride, Sodium Benzoate, Potassium Sorbate, Citric Acid, Biosaccharide Gum-4, Allantoin, Mentha Piperita (Peppermint) Leaf Juice, Maris Aqua (Dead Sea Water/Osmoter).
Other Information
Protect this product from excessive heat and direct sun.
Questions Or Comments
Call toll free 1-800-366-7254
Principal Display Panel - 50 Ml Bottle Carton
AHAVA
SPF 50+
Facial Skin Shield
Broad Specrtum
SPF 50+
PA++++
BROAD SPECTRUM UVB UVA
SUN
Principal Display Panel (50 ml Bottle Carton)
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