VITAMIN E SPF15 LIP BALM- avobenzone, octisalate, octocrylene stick
Autumn Harp, Inc.

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.

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Lip Care SPF 15 With Vitamin E

Drug Facts

Active Ingredient

Avobenzone (2.0%, w.w)

Octisalate (5.0%, w.w)

Octocrylene (3.0%, w/w)

Purpose

Sunscreen

Uses

* helps prevent sunburn

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 occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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 • protect the product in this container from excessive heat and direct sun.

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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VITAMIN E SPF15 LIP BALM
avobenzone, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51514-0342
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51514-0342-1	4.2 g in 1 CYLINDER; Type 0: Not a Combination Product	03/13/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	03/13/2013

Labeler - Autumn Harp, Inc. (064187883)

Name	Address	ID/FEI	Business Operations
Establishment
Autumn Harp, Inc.		064187883	manufacture(51514-0342)

Revised: 9/2019

Document Id: 9379ac93-77a9-1d26-e053-2a95a90ad240

Set id: 2ea1edb3-d8b3-1e8a-e054-00144ff88e88

Version: 2

Effective Time: 20190926

Autumn Harp, Inc.