OTC Medication Information: AL0038502 Alba Tropical Fruit Kids Sunscreen SPF40

AL0038502 ALBA TROPICAL FRUIT KIDS SUNSCREEN SPF40- homosalate, octocrylene, octisalate and avobenzone 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.

Avobenzone -3%

Homosalate -12.0%

Octocrylene — 7.0%

Octyl Salicylate — 5.0%

Sunscreen

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

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), Caprylic/Capric Triglyceride, Glycerin, Aloe Barbadensis Leaf Juice (1), VP/Hexadecene Copolymer, Sodium Stearoyl Glutamate, Dimethicone, Citrus Aurantium Dulcis (Orange) Peel Oil, Glycine Soja (Soybean) Oil, Calendula Officinalis Flower Extract (1), Camellia Sinensis Leaf Extract (1), Chamomilla Recuitita (Matricaria) Flower Extract (1), Gingko Biloba Root Extract, Olea Europaea (Olive) Leaf Extract, Panax Ginseng Root Extract (1), Tocopheryl Acetate, Alcohol (1), A-Terpinyl Acetate, Cetyl Alcohol, Citric Acid, Dimethylhydroxy Furanone, Glyceryl Stearate SE, Nonanal, Potassium Cetyl Phosphate, Sodium Chloride, Vanillin, Xanthan Gum, Benzyl Alcohol, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Limonene.


(1) Certified Organic Ingredient

888-659-7730, www.AlbaBotanica.com

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (HOMOSALATE) HOMOSALATE 12 g in 100 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 7 g in 100 g
OCTISALATE (OCTISALATE) OCTISALATE 5 g in 100 g
AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g in 100 g
Inactive Ingredients
Ingredient Name Strength
VINYLPYRROLIDONE/HEXADECENE COPOLYMER
MEDIUM-CHAIN TRIGLYCERIDES
WATER
GLYCERIN
SODIUM STEAROYL GLUTAMATE
DIMETHICONE
ALOE VERA LEAF
CALENDULA OFFICINALIS FLOWER
GREEN TEA LEAF
CHAMOMILE
OLEA EUROPAEA LEAF
GINKGO
ASIAN GINSENG
CETYL ALCOHOL
GLYCERYL MONOSTEARATE
CITRIC ACID MONOHYDRATE
POTASSIUM CETYL PHOSPHATE
SODIUM CHLORIDE
.ALPHA.-TOCOPHEROL ACETATE
XANTHAN GUM
ALCOHOL
BENZYL ALCOHOL
PHENOXYETHANOL
POTASSIUM SORBATE
SODIUM BENZOATE
ORANGE OIL
SOYBEAN OIL
TERPINYL ACETATE
DIMETHYLHYDROXY FURANONE
NONANAL
VANILLIN
LIMONENE, (+)-
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61995-2085-4 118 g in 1 BOTTLE, SPRAY None
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. (081512382)
Establishment
Name Address ID/FEI Operations
The Hain Celestial Group, Inc. 081512382 manufacture (61995-2085)

Revised: 04/2021 The Hain Celestial Group, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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