Fruit Smoothies
FDA Label NDC 10157-8014

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Blistex Inc. for the product Fruit Smoothies (NDC 10157-8014). 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 other, otc - purpose, uses, skin cancer/skin aging alert, otc - do not use, otc - when using, otc - stop use, package warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 - Kit Blister Pack

NDC 10157-8014-1

SPF 15

Blistex®

LIP PROTECTANT/SUNSCREEN

Fruit
Smoothies®

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

FREE
Orange
Cream
LIMITED EDITION
STICK

4 Sticks Net Wt. 0.10 oz. (2.83 g) Ea.

Principal Display Panel (Kit Blister Pack)

Principal Display Panel (Kit Blister Pack)

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