Label: VITAMIN E SPF15 LIP BALM- avobenzone, octisalate, octocrylene stick
- NDC Code(s): 51514-0342-1
- Packager: Autumn Harp, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 14, 2023
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- WARNINGS AND PRECAUTIONS
- Active Ingredient
- Purpose
- Uses
- Warnings
- WHEN USING
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
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INSTRUCTIONS FOR USE
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.
- DOSAGE & ADMINISTRATION
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Inactive Ingredients:
Ricinus Communis (Castor) Seed Oil, Olea Europaea (Olive) Fruit Oil, Beeswax, Hyrdogenated 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 (Vanilla), Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Tocopherol, Glycine Soja (Soybean) Oil
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INGREDIENTS AND APPEARANCE
VITAMIN E SPF15 LIP BALM
avobenzone, octisalate, octocrylene stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51514-0342 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 3 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 100 g Inactive Ingredients Ingredient Name Strength CASTOR OIL (UNII: D5340Y2I9G) YELLOW WAX (UNII: 2ZA36H0S2V) OLIVE OIL (UNII: 6UYK2W1W1E) COCONUT OIL (UNII: Q9L0O73W7L) 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) CANDELILLA WAX (UNII: WL0328HX19) Product Characteristics Color Score Shape Size Flavor VANILLA Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51514-0342-1 4.2 g in 1 CYLINDER; Type 0: Not a Combination Product 03/13/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 03/13/2013 Labeler - Autumn Harp, Inc. (064187883) Establishment Name Address ID/FEI Business Operations Autumn Harp, Inc. 064187883 manufacture(51514-0342)
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