Label: USANA LIP MOISTURIZER- avobenzone, octinoxate, octisalate lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 63645-128-02 - Packager: Oralabs
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated April 23, 2012
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Keep Out of Reach of Children
- Uses
- Warnings
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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
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
USANA LIP MOISTURIZER
avobenzone, octinoxate, octisalate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63645-128 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.0 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 g Inactive Ingredients Ingredient Name Strength COCONUT OIL (UNII: Q9L0O73W7L) 30 g CASTOR OIL (UNII: D5340Y2I9G) 23 g WHITE WAX (UNII: 7G1J5DA97F) 27.5 g COCOA BUTTER (UNII: 512OYT1CRR) 0.001 g SHEA BUTTER (UNII: K49155WL9Y) 0.001 g .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) 1.998 g PEAR JUICE (UNII: F214DLA9BE) 2.0 g Product Characteristics Color WHITE Score Shape Size Flavor FRUIT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63645-128-02 1 in 1 APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/06/2012 Labeler - Oralabs (801824756) Registrant - Usana (804413250) Establishment Name Address ID/FEI Business Operations OraLabs 801824756 LABEL(63645-128) , MANUFACTURE(63645-128)