ALBA BOTANICA NATURAL VERY EMOLLIENT SUNSCREEN SPORT SPRAY SPF40 - homosalate, ethylhexyl methoxycinnamate, octocrylene, ethylhexyl salicylate, butyl methoxydibenzoylmethane 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    12.0%

Ethylhexyl Methoxycinnamate   7.5%

Octocrylene    7.0%

Ethylhexyl Salicylate  5.0%

Butyl Methoxybenzoylmethane  3.0%

Sunscreen

For external use only. Do not use on damaged or broken skin. 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 15 minutes before sun exposure. Reapply after 80 min of swimming or sweating,after towel drying and at lease every two hrs. 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. To decrease a risk,regularly use a Sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially 10am- 2pm, wear long- sleeved shirts,pants, hats and sunglasses.

Aqua (Water), Aloe Barbadensis Leaf Juice (1), Glycerin, VP/Hexadecene Copolymer, Sodium Stearoyl Glutamate, Calendula Officinalis Flower Extract (1), Camellia Sinensis Leaf Extract (1), Chamomilla Recuitita (Matricaria) Flower Extract (1), Olea Europaea (Olive) Leaf Extract, Panax Ginseng Root Extract (1), Gingko Biloba Root Extract, Cetyl Alcohol, Citric Acid, Glyceryl Stearate SE, Potassium Cetyl Phosphate, Sodium Chloride, Tocopheryl Acetate, Xanthan Gum,  Alcohol (1), Benzyl Alcohol, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate.

(1) Certified Organic Ingredient

888-659-7730, www.AlbaBotanica.com

image of front label      image of back label
    

ALBA BOTANICA NATURAL VERY EMOLLIENT SUNSCREEN SPORT SPRAY SPF40 
homosalate, ethylhexyl methoxycinnamate, octocrylene, ethylhexyl salicylate, butyl methoxydibenzoylmethane lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2383
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE12 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.0 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CHAMOMILE (UNII: FGL3685T2X)  
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
GINKGO (UNII: 19FUJ2C58T)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ALCOHOL (UNII: 3K9958V90M)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-2383-4113 g in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/29/2011
Labeler - The Hain Celestial Group, Inc. (858894996)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group, Inc.858894996manufacture

Revised: 5/2012
Document Id: 13a42682-9ef2-4aba-93b5-76f19b394c9d
Set id: 5b8fae9b-83e2-44b9-a14f-296609f4e274
Version: 3
Effective Time: 20120508
 
The Hain Celestial Group, Inc.