VITAMIN E MOISTURE-PROTECT LIP CARE SPF 15- octisalate, avobenzone, and octocrylene stick

VITAMIN E MOISTURE-PROTECT LIP CARE SPF 15 by

Drug Labeling and Warnings

VITAMIN E MOISTURE-PROTECT LIP CARE SPF 15 by is a Otc medication manufactured, distributed, or labeled by The Body Shop, Wake Forest. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

ACTIVE INGREDIENTS	Purpose
Avobenzone (2.0% w/w)	Sunscreen
Octisalate (5.0% w/w)	Sunscreen
Octocrylene (3.0% w/w)	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, 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

THE
BODY
SHOP®

THE BODY SHOP
VITAMIN E
MOISTURE-PROTECT
LIP CARE

BROADSPECTRUM SPF 15
SUNSCREEN

WITH VITAMIN E
& MOISTURISING WHEATGERM OIL

ACTIVE INGREDIENTS:
Avobenzone (2.0%),
Octisalate (5.0%),
Octocrylene (3.0%).

Net wt. 4.2 g (0.14 OZ)

ALL SKIN TYPES

Peel for Drug Facts

INGREDIENTS AND APPEARANCE

VITAMIN E MOISTURE-PROTECT LIP CARE SPF 15 
octisalate, avobenzone, and octocrylene stick

Product 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)