ALBA BOTANICA UN-PETROLEUM VANILLA SPF18 LIP BALM - ethylhexyl dimethyl paba, benzophenone-3 stick 
The Hain Celestial Group, 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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Drug Facts

Ethylhexyl Dimethyl PABA       7.5%

Benzophenone-3      5.0%

Sunscreen

Helps prevent sunburn

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 skin rash occurs.

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

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

Skin Protection Measures:Spending time in the sun increases your risk of skin cancer and early skin aging.

Ricinus Communis (Castor) Seed Oil, Beeswax, Euphorbia Cerifera (Candelilla) Wax, Cocos Nucifera (Coconut) Oil, Simmondsia Chinensis (Jojoba) Seed Oil (1), Lanolin,  Copernicia Cerifera (Carnauba) Wax, Glycine Soja (Soybean) Oil, Oenothera Biennis (Evening Primrose) Oil, Olea Europaea (0live)Fruit Oil, Echinacea Purpurea Extract, Vanilla Planifolia Fruit Extract, Ammonium Glycyrrhizate, Tocopherol, Tocopheryl Acetate.



(1) Certified Organic Ingredient

Questions? Call 888-659-7730 or visit www.AlbaBotanica.com

  image of container label      image of carton label

ALBA BOTANICA UN-PETROLEUM VANILLA SPF18 LIP BALM 
ethylhexyl dimethyl paba, benzophenone-3 stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2921
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O7.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL (UNII: D5340Y2I9G)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CANDELILLA WAX (UNII: WL0328HX19)  
JOJOBA OIL (UNII: 724GKU717M)  
LANOLIN (UNII: 7EV65EAW6H)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SOYBEAN OIL (UNII: 241ATL177A)  
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
ECHINACEA PURPUREA (UNII: QI7G114Y98)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
COCONUT OIL (UNII: Q9L0O73W7L)  
VANILLA (UNII: Q74T35078H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-2921-11 in 1 CARTON
14.2 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/02/2011
Labeler - The Hain Celestial Group, Inc. (858894996)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group, Inc.858894996manufacture

Revised: 5/2012
Document Id: 30695b6c-a104-441c-bc7b-39b6e86fcfc2
Set id: 88b44518-5dc8-4791-92f3-eed4b70061e1
Version: 1
Effective Time: 20120510
 
The Hain Celestial Group, Inc.