VITAMIN E MOISTURE-PROTECT LIP CARE SPF 15- octisalate, avobenzone, and octocrylene stick 
The Body Shop, Wake Forest

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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VITAMIN E MOISTURE-PROTECT LIP CARE SPF 15

Drug Facts

ACTIVE INGREDIENTSPurpose
Avobenzone (2.0% w/w)Sunscreen
Octisalate (5.0% w/w)Sunscreen
Octocrylene (3.0% w/w)Sunscreen

Uses

Warnings

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

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

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

Principal Display Panel - 4.2 g Container
VITAMIN E MOISTURE-PROTECT LIP CARE SPF 15 
octisalate, avobenzone, and octocrylene stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57691-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.05 g  in 1 g
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.02 g  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.03 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57691-002-424.2 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35204/14/2016
Labeler - The Body Shop, Wake Forest (791071279)

Revised: 3/2016
Document Id: 931da763-2cf8-407d-a76a-e52d33417798
Set id: 16dd7500-92c1-4c9d-84d2-e9294e2f415b
Version: 1
Effective Time: 20160318
 
The Body Shop, Wake Forest