Shield By Healthy Skin Lab Md Sunscreen Cream
FDA Label NDC 87469-102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Healthy Skin Lab Limited for the product Shield By Healthy Skin Lab Md Sunscreen (NDC 87469-102). 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 drug facts, active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Titanium dioxide 5.5% w/v
Zinc oxide 10% w/v
Purpose
Sunscreen
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 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
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 to the face and body, avoiding eye area 15 minutes before sun exposure
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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
• children under 6 months of age: Ask a doctor
Other Information
• protect the product in this container from excessive heat and direct sun
Inactive Ingredients
Alumina, C12-15 Alkyl Benzoate, Caprylyl Glycol, Caprylyl Methicone, Cyclomethicone 5, Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Disodium EDTA, Disteardimonium Hectorite, Ethylhexylglycerin, Glycerin, 1,2-Hexanediol, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Methicone, Phenoxyethanol, Polyhydroxystearic Acid, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Propylene Carbonate, Sodium Chloride, Triethoxycaprylylsilane, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Water (Aqua)
Questions Or Comments?
1-646-351-8635
You may also report serious side effects to this phone number.
Mon - Fri 9:00 AM - 5:00 PM
Packaging
Shieldbyhslabmdsunscreen (87469102 2)
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