ALBA BOTANICA NATURAL EVEN ADVANCED SEA MOSS MOISTURIZER SPF15 - homosalate, octocrylene, ethylhexyl salicylate  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.

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Drug Facts

Homosalate    7.5%

Octocrylene    5.0%

Ethylhexyl Salicylate  5.0%


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 daily to clean face and neck. Apply at least 15 minutes before and every 2 hours during sun exposure. Children under 6 months: ask a doctor.
Skin protection measures: 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, not skin cancer and early skin aging.

Aqua (Water), Caprylic/Capric Triglyceride, Glycerin, Glyceryl Stearate SE, Cetearyl Olivate, Sorbitan Olivate,   VP/Hexadecene Copolymer, Hydrogenated Palm Kernel Oil, Aloe Barbadensis Leaf Juice (1), Chondrus Crispus (Sarrageenan) Extract (1) (2), Camellia Sinensis Leaf Extract (1), Chamomilla Recuitita (Matricaria) Flower Extract (1), Laminaria Digitata  Extract, Macrocystis Purifera Extract, Spirulina Maxima Extract, Ulva Lactuca Extract (1), Cetyl Alcohol, Allantoin  Ascorbic Acid, Ascorbyl Glucoside, Carthamus Tinctorius (Safflower) Oleosomes, Diacetyl Boldine, Erythritol, Homarine HCl, Montmorillonite, Panthenol ,Sodium Stearoyl Glutamate, Ethylhexylglycerin, Gluconolactone, Tocopheryl Acetate, Xanthan Gum,  Alcohol (1), Benzyl Alcohol, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Benzyl Benzoate, Hexyl Cinnamal, Limonene, Linalool, Fragrance (Parfum).

(1) Certified Organic Ingredient

(2) Sea Moss Extract

888-659-7730, www.AlbaBotanica.com

image of tube label       image of carton label
    

ALBA BOTANICA NATURAL EVEN ADVANCED SEA MOSS MOISTURIZER SPF15 
homosalate, octocrylene, ethylhexyl salicylate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2312
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5.0 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CHAMOMILE (UNII: FGL3685T2X)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
SPIRULINA MAXIMA (UNII: 9K7IG15M0Q)  
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
ULVA LACTUCA (UNII: PHR3P25W6Y)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ALCOHOL (UNII: 3K9958V90M)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ALLANTOIN (UNII: 344S277G0Z)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
DIACETYL BOLDINE (UNII: 37727Z7M0I)  
ERYTHRITOL (UNII: RA96B954X6)  
HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N)  
MONTMORILLONITE (UNII: A585MN1H2L)  
PANTHENOL (UNII: WV9CM0O67Z)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-2312-21 in 1 CARTON
157 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/02/2011
Labeler - The Hain Celestial Group, Inc. (858894996)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group, Inc.858894996manufacture

Revised: 5/2012
Document Id: 689b437a-207a-469b-9d1b-93279bce233d
Set id: 100cdec6-e691-4040-8193-5e544c27c327
Version: 1
Effective Time: 20120518
 
The Hain Celestial Group, Inc.