Otc - Active Ingredient
Avobenzone 2.7%
Octisalate 4.5%
Homosalate13.5%
Octocrylene 9%
P.calm Water Barrier Sunscreen Spf 50 Broad Spectrum Lotion
FDA Label NDC 83735-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Life Withcorporation Inc. for the product P.calm Water Barrier Sunscreen Spf 50 Broad Spectrum (NDC 83735-002). 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, indications & usage, warnings, do not use, when using this product, stop use and ask a doctor if rash occurs, 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
sunscreen
Indications & Usage
- helps prevent sunburn
- if used as directed with other sun protection (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 skin 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
- rash occurs
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away
Dosage & Administration
- apply liberally 15 minutes before sun exposure
- children under 6 months of age: Ask a doctor
- 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 a.m.-2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses
Other
- protect the product from excessive heat and direct sun
- Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun
Inactive Ingredient
Water, Butyloctyl Salicylate, Diethylhexyl 2,6-Naphthalate, Dipropylene Glycol, Panthenol, C20-22 Alkyl Phosphate, C20-22 Alcohols, 1,2-Hexanediol, Caprylyl Methicone, Silica, Pentylene Glycol, Cetyl Alcohol, Glyceryl Stearate, Polymethylsilsesquioxane, VP/Eicosene Copolymer,Tromethamine, Polyacrylate Crosspolymer-6, Ammonium Acryloyldimethyltaurate/VP Copolymer, Ethylhexylglycerin, Hydrolyzed Sodium Hyaluronate, Tocopherol, Butylene Glycol, Centella Asiatica Extract, Camellia Sinensis Leaf Extract
Package Label.Principal Display Panel
P.CALM Water Barrier Sunscreen
SPF 50+ Broad Spectrum
Panthenol, Hydrolyzed Sodium Hyaluronate, Centella Asiatica Extract
50mL - 1.69 fl.ox
Package Label
P.CALM Water Barrier Sunscreen
SPF 50+ Broad Spectrum
Panthenol, Hydrolyzed Sodium Hyaluronate, Centella Asiatica Extract
50 ml - 1.69 fl.oz
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