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  5. Label Information: P.calm Water Barrier Suncream

FDA Label for P.calm Water Barrier Suncream

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. DOSAGE & ADMINISTRATION
    5. WARNINGS
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. INACTIVE INGREDIENT
    8. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

P.calm Water Barrier Suncream Product Label

The following document was submitted to the FDA by the labeler of this product Life With Corporation 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



ETHYLHEXYL TRIAZONE 2.7%
TEREPHTHALYLIDENE DICAMPHOR SULFONIC ACID 2.64% 
POLYSILICONE-15 1%
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE 1%
BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE 0.5%


Otc - Purpose



Sunscreen


Indications & Usage



Helps prevent sunburn


Dosage & Administration



Apply liberally 15 minutes before sun exposure. Reapply at least every two hours


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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses

Ask a doctor to use for children under 6 months


Warnings



For external use only

Do not use on damaged or broken skin

Stop using and ask a doctor if rash occurs

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 product is swallowed, get medical help or contact a Poison Control Center right away


Inactive Ingredient



WATER, PROPANEDIOL, BUTYLOCTYL SALICYLATE, DIBUTYL ADIPATE, NIACINAMIDE, TROMETHAMINE, POLYGLYCERYL-3 DISTEARATE, OCTYLDODECANOL, CETEARYL ALCOHOL, 1,2-HEXANEDIOL, PENTYLENE GLYCOL, CAPRYLYL METHICONE, POLYMETHYLSILSESQUIOXANE, GLYCERYL STEARATE, POTASSIUM CETYL PHOSPHATE, METHYLPROPANEDIOL, POLY C10-30 ALKYL ACRYLATE, CARBOMER, GLYCERYL STEARATE CITRATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ETHYLHEXYLGLYCERIN, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, ADENOSINE, POLYETHER-1, SODIUM GUAIAZULENE SULFONATE, BIOSACCHARIDE GUM-1, CERAMIDE NP, ALLANTOIN, GLUTATHIONE, MADECASSOSIDE, LACTOBACILLUS FERMENT, BUTYLENE GLYCOL, ALOE FEROX LEAF EXTRACT


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