AL00378 ALBA COOL SPORT SUNSCREEN SPF50- avobenzone, homosalate, octocrylene, octyl salicylate spray 
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.

----------

Alba Cool Sport SPF 50 Sunscreen

Avobenzone 3.0%

Homosalate 15.0%

Octocrylene 8.0%

Octyl Salicylate 5.0%


Sunscreen

For external use only. Flammable.Do not use near heat, sparks or flames or while smoking. Do not puncture orincinerate. Contents under preassure .Do not store at temperature above 120°C. Do not use on damaged or broken skin. When using this product keep out of eye. 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.Hold 4 to 6 inches away from body when spraying. Do not spray directly on face and avoid breathing mist. Spray on hand and apply to face. Use in well- ventilated areas. Reapply after 80 min of swimming or sweating, immediately after towel drying and at lease every two hrs. 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. 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.

Alcohol, Acrylates/Octylacrylamide Copolymer, Persea Gratissima (Avocado) Oil, Diisopropyl Adipate, Citrus Limon (lemon) Oil, Aloe Barbadensis Leaf Juice, Amyris Balsamifera Bark Oil, Camellia Sinensis Leaf Extract, Chamomilla Recuitita (Matricaria) Flower Extract, Panax Ginseng Root Extract, Gingko Biloba Root Extract, Tocopheryl Acetate, Triethyl Citrate, Benzyl Salicylate, Citral, Citronellol, Hexyl Cinnamal, Hydroxycitronellol, Limonene.






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

bottle label

AL00378 ALBA COOL SPORT SUNSCREEN SPF50 
avobenzone, homosalate, octocrylene, octyl salicylate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2378
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CHAMOMILE (UNII: FGL3685T2X)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
GINKGO (UNII: 19FUJ2C58T)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALCOHOL (UNII: 3K9958V90M)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
AMYRIS BALSAMIFERA OIL (UNII: I1BJ961J2E)  
LEMON OIL (UNII: I9GRO824LL)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-2378-6177 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/14/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/14/2016
Labeler - The Hain Celestial Group, Inc. (117115556)
Registrant - The Hain Celestial Group, Inc. (014334364)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group Inc.081512382manufacture(61995-2378)

Revised: 2/2021
Document Id: baa04ed7-1af0-6df2-e053-2a95a90a89c0
Set id: 456017cd-3961-3263-e054-00144ff8d46c
Version: 3
Effective Time: 20210205
 
The Hain Celestial Group, Inc.