ALBA VERY EMOLLIENT SUNSCREEN LIP CARE SPF25- octocrylene, octinoxate, octisalate, zinc oxide 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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Alba Very Emollient Sunscreen Lip Care SPF25

Active Ingredient

Octocrylene 10.0%

Ethylhexyl Methoxycinnamate 7.5%

Zinc Oxide 3.7%

Ethylhexyl Salicylate 1.0%

Purpose

Sunscreen

Sunscreen

Sunscreen

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 doctor if skin rash occurs. Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging.

Directions

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Children under 6 months: ask a doctor.

Inactive Ingredients

Beeswax*, Helianthus Annuus (Sunflower) Seed Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Olea Europaea (Olive) Fruit Oil*, Ricinus Communis (Castor) Seed Oil*, C12-15 Alkyl Benzoate, Flavor*, Euphorbia Cerifera (Candelilla) Wax, Copernicia Cerifera (Carnauba) Wax*, Butyrospermum Parkii (Shea Butter)*, Theobroma Cacao (Cocoa) Seed Butter*, Glycine Soya (Soybean) Oil, Oenothera Biennis (Evening Primrose) Oil, Aloe Barbadensis Leaf Extract*, Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Allantoin, Ammonium Glycyrrhizate, Tocopherol, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Iron Oxides (CI 77491), * Certified Organic Ingredient

Other Information

Protect this product from excessive heat and direct sun

Questions?

Call (888) 659-7730 or visit www.albabotanica.com

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ALBA VERY EMOLLIENT SUNSCREEN LIP CARE SPF25 
octocrylene, octinoxate, octisalate, zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0306
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10.0 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.0 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC Oxide - UNII:SOI2LOH54Z) ZINC OXIDE3.7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
JOJOBA OIL (UNII: 724GKU717M)  
CASTOR OIL (UNII: D5340Y2I9G)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
VANILLA (UNII: Q74T35078H)  
CANDELILLA WAX (UNII: WL0328HX19)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SHEA BUTTER (UNII: K49155WL9Y)  
COCOA BUTTER (UNII: 512OYT1CRR)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SOYBEAN OIL (UNII: 241ATL177A)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
ALLANTOIN (UNII: 344S277G0Z)  
ECHINACEA PURPUREA (UNII: QI7G114Y98)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorVANILLAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51514-0306-14.2 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2012
Labeler - Autumn Harp, Inc. (064187883)
Establishment
NameAddressID/FEIBusiness Operations
Autumn Harp, Inc.064187883manufacture(51514-0306)

Revised: 9/2013
Document Id: 06100db1-4158-4b92-9413-d29cec8dcc13
Set id: 0f2b43ae-a05b-44d6-b002-ac78fead5d83
Version: 1
Effective Time: 20130917
 
Autumn Harp, Inc.