FDA Label for Moisturising Sunscreen Spf 30

View Indications, Usage & Precautions

Moisturising Sunscreen Spf 30 Product Label

The following document was submitted to the FDA by the labeler of this product Eshu Pty Ltd. 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



Active ingredients                   Purpose

Homosalate  8%                   Sunscreen

Octisalate  4%                      Sunscreen

Octinoxate  3%                     Sunscreen

Octocrylene  2%                   Sunscreen


Otc - Purpose



Uses

-Helps prevent sunburn

-higher SPF gives more sunburn protection

-provides high protection against sunburn

-for skin highly sensitive to sunburn


Otc - Keep Out Of Reach Of Children



Keep out of reach of children


Indications & Usage



-Stop use and ask a  doctor if rash or irritation occurs. -Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce risk of skin aging, skin cancer, and other harmful effects of the sun-Does not provide protection for already burnt skin-every case of sunburn damages the skin permanently -does not provide 100% protection against UV radiation-store in a cool dry place-keep carton. It contains important information

Warnings



warnings

For external use only

When using this product keep out of eyes. rinse with water to remove

If swallowed, get medical help or call a poison control center right away


Dosage & Administration



Directions-apply liberally and generously onto clean, dry skin and rub in evenly 20 minutes prior to sun exposure-apply enough to give a visible layer before rubbing in .-re-apply as needed every 1-2 hours, or after towel drying, swimming, or perspiring.-Children under 6 years of age: ask a doctor.

Inactive Ingredient



Inactive ingredients

Allantoin, Ammonium Acryloyldimethicone/VP copolymer, Caprylyl Glycol, Ceteareth-20, Cetearyl Alcohol, Cetyl Dimethicone, Cylcomethicone, Disodium  EDTA, Ethyl Linoleate, Fragrance, Isostearyl Neopentoate, Lactic Acid, Glycerin, Peg-40 Stearate, Polypropylene, Xanthan gum, Octanohydroxamic acid, Oleyl Alcohol, Panthenol, Panthenyl Triacetate, Pentylene Glycol, Serine, Silica, Sodium chloride, Sodium Lactate, Sorbitol, Tocopherol, Triacontanyl PVP, Urea, water.


Package Label.Principal Display Panel




Moisturizing Sunscreen SPF 30+

100 mL/3.4 oz




* Please review the disclaimer below.