AL0038200 ALBA VE SUNSCREEN KIDS SPF50- homosalate, octocrylene, ethylhexyl salicylate, butyl methoxydibenzoylmethane spray

AL0038200 Alba VE Sunscreen Kids SPF50 by

Drug Labeling and Warnings

AL0038200 Alba VE Sunscreen Kids 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

Homosalate 15.0%

Ethylhexyl Methoxycinnamate 7.5%

Octocrylene 8.0%

Ethylhexyl Salicylate 5.0%

Butyl Methoxybenzoylmethane 3.0%

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 Aurantium Dulcis (Orange) Peel Oil, Glucine Soja (Soybean) Oil, Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomilla Recuitita (Matricaria) Flower Extract, Panax Ginseng Root Extract, Gingko Biloba Root Extract, A-Terpinyl Acetate, Dimethylhydroxy Furanone, Glycerin,Nonanal, Tocopheryl Acetate,Vanillin, Potassium Sorbate, Sodium Benzoate, Limonene, Linalool.

QUESTIONS

888-659-7730 or visit www.AlbaBotanica.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AL0038200 ALBA VE SUNSCREEN KIDS SPF50 
homosalate, octocrylene, ethylhexyl salicylate, butyl methoxydibenzoylmethane spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-2382
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
SOYBEAN OIL (UNII: 241ATL177A)
TERPINYL ACETATE (UNII: NIT9SZT3D7)
DIMETHYLHYDROXY FURANONE (UNII: 20PI8YZP7A)
VANILLIN (UNII: CHI530446X)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
ORANGE OIL (UNII: AKN3KSD11B)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GINKGO (UNII: 19FUJ2C58T)
ASIAN GINSENG (UNII: CUQ3A77YXI)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALCOHOL (UNII: 3K9958V90M)
AVOCADO OIL (UNII: 6VNO72PFC1)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
NONANAL (UNII: 2L2WBY9K6T)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-2382-6	177 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/03/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/03/2015

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

Establishment
Name	Address	ID/FEI	Business Operations
The Hain Celestial Group Inc.		117115556	manufacture(61995-2382)