FDA Label for Fruit Smoothies

View Indications, Usage & Precautions

Fruit Smoothies Product Label

The following document was submitted to the FDA by the labeler of this product Blistex 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.

Other



Drug Facts

For external use only


Otc - Purpose



Active ingredientsPurpose
Dimethicone 1.0% (w/w)Lip protectant
Octinoxate 7.5% (w/w)Sunscreen
Oxybenzone 2.5% (w/w)Sunscreen

Uses



  • temporarily protects and helps relieve chapped or cracked lips
  • helps prevent sunburn

Skin Cancer/Skin Aging Alert



Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.


Otc - Do Not Use



Do not use on damaged or broken skin


Otc - When Using



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


Otc - Stop Use



Stop use and ask a doctor if rash occurs


Package Warning



CHOKING HAZARD. Has removable cap. Not for children under 3 years.


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 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • 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, beeswax, blue 1 lake

May contain one or more of these ingredients.

, diethylhexyl adipate, ethylhexyl palmitate, ethylhexyl stearate, flavors, glyceryl stearate, hydrogenated coconut oil, isopropyl myristate, isopropyl palmitate, isopropyl stearate, jojoba esters, microcrystalline wax, myristyl myristate, phenoxyethanol, phenyl trimethicone, polyethylene, polyhydroxystearic acid, red 30 lake, saccharin, silica, tetrahexyldecyl ascorbate, titanium dioxide, tocopheryl acetate, yellow 10


Principal Display Panel - 4 Stick Blister Pack



NDC 10157-8013-1

SPF 15

Blistex®
LIP PROTECTANT/SUNSCREEN

Fruit
Smoothies
®

4 Creamy Blends With Delicious
Fruit Flavors And Vitamins C&E

FREE

Peaches
& Cream

LIMITED EDITION
STICK

4 STICKS NET WT. .10 oz (2.83g) EACH


* Please review the disclaimer below.