Vitamin E Spf15 Lip Balm (Avobenzone, Octisalate, Octocrylene) Stick [Autumn Harp, Inc.] -

VITAMIN E SPF15 LIP BALM (AVOBENZONE, OCTISALATE, OCTOCRYLENE) STICK [AUTUMN HARP, INC.]
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NDC	51514-0342-1
Set ID	2ea1edb3-d8b3-1e8a-e054-00144ff88e88
Category	HUMAN OTC DRUG LABEL
Packager	Autumn Harp, Inc.
Generic Name
Product Class
Product Number
Application Number	PART352

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WARNINGS AND PRECAUTIONS

Drug Facts
Active Ingredient

Avobenzone (2.0%, w.w)

Octisalate (5.0%, w.w)

Octocrylene (3.0%, w/w)
Purpose

Sunscreen

Sunscreen

Sunscreen
Uses

* helps prevent sunburn
Warnings
- For external use only
Do not use • on damaged or broken skin
WHEN USING

When using this product • keep out of eyes. Rinse with water to remove.
ASK DOCTOR

Stop use and ask a doctor if • rash occurs.
KEEP OUT OF REACH OF CHILDREN

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

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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INGREDIENTS AND APPEARANCE

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)

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Medic

VITAMIN E SPF15 LIP BALM (AVOBENZONE, OCTISALATE, OCTOCRYLENE) STICK [AUTUMN HARP, INC.]

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