NDC | 57691-002-42 |
Set ID | 16dd7500-92c1-4c9d-84d2-e9294e2f415b |
Category | HUMAN OTC DRUG LABEL |
Packager | The Body Shop, Wake Forest |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
-
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
-
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
-
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)