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

AL00378 Alba Cool Sport Sunscreen SPF50 by

Drug Labeling and Warnings

AL00378 Alba Cool Sport Sunscreen SPF50 by is a Otc medication manufactured, distributed, or labeled by The Hain Celestial Group, Inc., The Hain Celestial Group Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 3.0%

Homosalate 15.0%

Octocrylene 8.0%

Octyl Salicylate 5.0%

PURPOSE

Sunscreen

INDICATIONS & USAGE

• Helps prevent sunburn. If uses as directed with other sun protection measures (see Directions), decreases risk of skin cancer and early skin aging caused by the sun.
  

WARNINGS

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

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

DOSAGE & ADMINISTRATION

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.

INACTIVE INGREDIENT

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-2378
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-2378-6	177 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/14/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/14/2016

Labeler - The Hain Celestial Group, Inc. (117115556)

Registrant - The Hain Celestial Group, Inc. (014334364)

Establishment
Name	Address	ID/FEI	Business Operations
The Hain Celestial Group Inc.		117115556	manufacture(61995-2378)