Label: VITAMIN E MOISTURE-PROTECT LIP CARE SPF 15- octisalate, avobenzone, and octocrylene stick
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Contains inactivated NDC Code(s)
NDC Code(s): 57691-002-42 - Packager: The Body Shop, Wake Forest
- 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 March 18, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
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Directions
- Apply liberally 15 minutes before sun exposure.
- 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 value of 15 or higher and other sun protection measures including:
- limit time in sun especially from 10 a.m. – 2 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses.
- reapply this product at least every 2 hours.
- use water resistant sunscreen if swimming or sweating.
- children under 6 months of age: ask a doctor.
- Other information
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Inactive Ingredients
Ricinus Communis (Castor) Seed Oil, Olea Europaea (Olive) Fruit Oil, Beeswax, Hydrogenated Coconut Oil, Euphorbia Cerifera (Candelilla) Wax, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Tocopheryl Acetate, Ammonium Glycyrrhizate, Triticum Vulgare (Wheat) Germ Oil, Vanilla Planifolia Fruit Extract, Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Tocopherol, Glycine Soja (Soybean) Oil.
- PRINCIPAL DISPLAY PANEL - 4.2 g Container
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INGREDIENTS AND APPEARANCE
VITAMIN E MOISTURE-PROTECT LIP CARE SPF 15
octisalate, avobenzone, and octocrylene stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57691-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.05 g in 1 g Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.02 g in 1 g Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 0.03 g in 1 g Inactive Ingredients Ingredient Name Strength CASTOR OIL (UNII: D5340Y2I9G) OLIVE OIL (UNII: 6UYK2W1W1E) YELLOW WAX (UNII: 2ZA36H0S2V) Hydrogenated Coconut Oil (UNII: JY81OXM1OM) CANDELILLA WAX (UNII: WL0328HX19) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Ammonium Glycyrrhizate (UNII: 3VRD35U26C) WHEAT GERM OIL (UNII: 14C97E680P) Vanilla (UNII: Q74T35078H) Calendula Officinalis Flower (UNII: P0M7O4Y7YD) Echinacea Purpurea (UNII: QI7G114Y98) Tocopherol (UNII: R0ZB2556P8) SOYBEAN OIL (UNII: 241ATL177A) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57691-002-42 4.2 g in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 04/14/2016 Labeler - The Body Shop, Wake Forest (791071279)
