AL0038502 ALBA TROPICAL FRUIT KIDS SUNSCREEN SPF40- homosalate, octocrylene, ethylhexyl salicylate, avobenzone spray

AL0038502 Alba Tropical Fruit Kids Sunscreen SPF40 by

Drug Labeling and Warnings

AL0038502 Alba Tropical Fruit Kids Sunscreen SPF40 by is a Otc medication manufactured, distributed, or labeled by The Hain Celestial Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone -3%

Homosalate -12.0%

Octocrylene - 7.0%

Octyl Salicylate - 5.0%

PURPOSE

Sunscreen

INDICATIONS & USAGE

• Helps prevent sunburn. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun.
  

WARNINGS

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

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. 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.

INACTIVE INGREDIENT

Aqua (Water), Caprylic/Capric Triglyceride, Glycerin, Aloe Barbadensis Leaf Juice (1), VP/Hexadecene Copolymer, Sodium Stearoyl Glutamate, Dimethicone, 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,Citrus Aurantium Dulcis (Orange) Peel Oil, Glycine Soja (Soybean) Oil,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, A-Terpinyl Acetate, Dimethylhydroxy Furanone, Nonanal, Vanillin, Limonene.



(1) Certified Organic Ingredient

QUESTIONS

888-659-7730, www.AlbaBotanica.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AL0038502 ALBA TROPICAL FRUIT KIDS SUNSCREEN SPF40 
homosalate, octocrylene, ethylhexyl salicylate, avobenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-2085
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	12 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 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

Inactive Ingredients
Ingredient Name	Strength
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
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)
ORANGE OIL (UNII: AKN3KSD11B)
SOYBEAN OIL (UNII: 241ATL177A)
TERPINYL ACETATE (UNII: NIT9SZT3D7)
DIMETHYLHYDROXY FURANONE (UNII: 20PI8YZP7A)
NONANAL (UNII: 2L2WBY9K6T)
VANILLIN (UNII: CHI530446X)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-2085-4	118 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/13/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/13/2016

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(61995-2085)