USANA Lip Moisturizer

Dosage form: lipstick
Ingredients: AVOBENZONE 3.0g, OCTINOXATE 7.5g, OCTISALATE 5.0g
Labeler: Oralabs
NDC Code: 63645-128

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient

Avobenzone 3.0%

Octinoxate 7.5%

Octisalate 5.0%

Purpose

Sunscreen

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Helps prevent sunburn. Help prevent and temporarily protect dry, chapped, or windburned lips if used as directed with other sun protection measures (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 or broken skin. When using this product, keep out of eyes. Rinse with water to remove. Stop use and ask a doctor: if rash or irritation develops.

Directions

Apply liberally before sun exposure and as needed.

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 or higher and other sun protection measures including: limiting time in the sun (especially from 10 a.m. - 2 p.m.) and wearing long-sleeve shirts, pants, hats, and sunglasses.

Children under 6 months of age: Ask a doctor before use.

Inactive ingredients

Cocos Nucifera (Coconut) Oil, Beeswax, Ricinus Communis (Castor) Seed Oil, Flavor, Tocopherol, Butyrospermum Parki (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter

Package/Label Principal Display Panel
USANA LIP MOISTURIZER 
avobenzone, octinoxate, octisalate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63645-128
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE3.0 g
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g
OCTISALATE (OCTISALATE) OCTISALATE5.0 g
Inactive Ingredients
Ingredient NameStrength
COCONUT OIL30 g
CASTOR OIL23 g
WHITE WAX27.5 g
COCOA BUTTER0.001 g
SHEA BUTTER0.001 g
.ALPHA.-TOCOPHEROL1.998 g
PEAR JUICE2.0 g
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63645-128-021 LIPSTICK in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/06/2012
Labeler - Oralabs (801824756)
Registrant - Usana (804413250)
Establishment
NameAddressID/FEIOperations
OraLabs801824756LABEL(63645-128), MANUFACTURE(63645-128)

Revised: 04/2012
 
Oralabs

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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