FDA Label for P.calm Water Barrier Sunscreen Spf 50 Broad Spectrum

View Indications, Usage & Precautions

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
DOSAGE & ADMINISTRATION
OTHER
INACTIVE INGREDIENT
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL

P.calm Water Barrier Sunscreen Spf 50 Broad Spectrum Product Label

The following document was submitted to the FDA by the labeler of this product Life Withcorporation Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient

Avobenzone 2.7%

Octisalate 4.5%

Homosalate13.5%

Octocrylene 9%

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

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

children under 6 months of age: Ask a doctor
reapply at least every 2 hours
use a water resistant sunscreen if swimming or sweating

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