ALBA BOTANICA NATURAL VERY EMOLLIENT DAILY SHADE SPF15 - homosalate, ethylhexyl salicylate, octocrylene lotion 
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.

----------

Drug Facts

Homosalate  7.5%

Ethylhexyl Salicylate  5.0

Octocrylene 3.0%

Sunscreen

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 a Poison Control Center right away.

Apply liberally over entire body after bath or shower, at least 15 minutes before sun exposure and every 2 hours during sun exposure. Children under 6 months ask a doctor.

Aqua (Water), Caprylic/Capric Triglyceride, Glycerin, Glyceryl Stearate SE, Carthamus Tinctorius (Safflower) Oil, Cetearyl Alcohol,  Hydrogenated Palm Kernel Oil, Butyrospermum Parkii (Shea Butter), Persea Gratissima (Avocado) Oil, Sesamum Indicum (Sesame) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil (1), Vitus Vinifera (Grape) Seed Oil, Aloe Barbadensis Leaf Juice (1), Camellia Sinenensis Leaf Extract (1), Chamomilla Recutita (Matricaria ) Flower Extract (1), Cucumus Sativus (Cucumber) Fruit Extract, Echinacea Angustifolia Extract, Lavandula Angustifolia (Lavender) Extract (1), Allantoin, Ascorbic Acid, Glycolic Acid, Lactic Acid, Lecithin, Panthenol, Polysorbate 60, Potassium Hydroxide, Tocopheryl Acetate, Alcohol (1), Xanthan Gum, Benzoic Acid, Dehydroacetic Acid, Phenoxyethanol, Fragrance (Parfum)


(1) Certified Organic Ingredients

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

image of bottle label

ALBA BOTANICA NATURAL VERY EMOLLIENT DAILY SHADE SPF15 
homosalate, ethylhexyl salicylate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2371
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-2371-2340 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/18/2011
Labeler - The Hain Celestial Group, Inc. (858894996)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group, Inc.858894996manufacture

Revised: 4/2012
Document Id: 632dbe73-b92d-4b92-b892-1b694451bbbb
Set id: eb3d2c86-6483-4f18-80e5-d54c774a6ffd
Version: 1
Effective Time: 20120426
 
The Hain Celestial Group, Inc.