LIP CARE SPF 15 WITH VITAMIN E- octinoxate, oxybenzone 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

Octinoxate (7.5% w/w)

Oxybenzone (5.0% w/w)

Purpose

Sunscreen

Sunscreen

Uses

• Helps prevent sunburn

Warnings

• Skin Cancer/Skin Aging Alert Spending time in the sun increases your risk of skin cancer and early skin aging.  This product has been shown only to help prevent sunburn, skin cancer or early skin aging.

• For external use only. 

Don 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. • 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, Hydrogenated Coconut Oil, Olea Europaea (Olive) Fruit Oil, Beeswax, Euphorbia Cerifera (Candelilla) Wax, Cocos Nucifera (Coconut) Oil, Tocopheryl Acetate, Vanilla Planifolia Extract,Ammonium Glycyrrhizate, Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Tocopherol, Glycine Soja (Soybean) Oil.

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LIP CARE SPF 15 WITH VITAMIN E 
octinoxate, oxybenzone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0336
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL (UNII: D5340Y2I9G)  
COCONUT OIL (UNII: Q9L0O73W7L)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CANDELILLA WAX (UNII: WL0328HX19)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
VANILLA (UNII: Q74T35078H)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
ECHINACEA PURPUREA (UNII: QI7G114Y98)  
SOYBEAN OIL (UNII: 241ATL177A)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
Product Characteristics
Color    Score    
ShapeSize
FlavorVANILLAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51514-0336-14.2 g in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/20/2004
Labeler - Autumn Harp, Inc. (064187883)
Establishment
NameAddressID/FEIBusiness Operations
Autumn Harp, Inc.064187883manufacture(51514-0336)

Revised: 1/2014
Document Id: 3153033b-7552-4484-a4db-f403330ef2ee
Set id: 14e6dc52-045d-45ca-9633-16fa244d1a68
Version: 1
Effective Time: 20140130
 
Autumn Harp, Inc.