Alba Botanica Kids SunscreenTropical Fruit SPF45

Manufacturer
The Hain Celestial Group, Inc.
Effective date
2021-04-12
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:39:37

Label at a glance#

ProductAlba Botanica Kids SunscreenTropical Fruit SPF45
Active ingredientHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Avobenzone - 3.0%

Homosalate - 10.0%

Octocrylene - 10.0%

Octyl Salicylate - 5.0%

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours.

OTC - PURPOSE SECTION

Sunscreen

WARNINGS SECTION

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INACTIVE INGREDIENT SECTION

Water, Cetyl Alcohol, Glycerin,Glyceryl Stearate SE, Dimethicone, Caprylic/Capric Triglyceride, VP/Hexadecene Copolymer, Cetearyl Alcohol, Citrus Aurantium Dulcis (Orange) Peel Oil, Glycine Soja (Soybean) Oil, Aloe Barbadensis Leaf Juice(1), Calendula Officinalis Flower Extract (1), Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Ginkgo Biloba Leaf Extract, Lavandula Angustifolia (Lavender) Extract (1), Panax Ginseng Root Extract, Tocopheryl Acetate, Alcohol (1), A-Terpinyl Acetate, Cetearyl Alcohol, Cetearyl Olivate, Citric Acid, Dimethylhydroxy Furanone, Nonanal, Polysorbate 60, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Vanillin, Xanthan Gum, Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate, Limonene.

(1) Certified Organic Ingredient

INDICATIONS & USAGE SECTION

Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AL00399 LabelAL00399 Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61995-2099-4Alba Botanica Kids SunscreenTropical Fruit SPF45113 g in 1 TUBELOTION1136

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61995-2099ALBA BOTANICA KIDS SUNSCREENTROPICAL FRUIT SPF45 (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATE) LOTION [THE HAIN CELESTIAL GROUP, INC.]6Legacy NDC, 1 package rows20210413_65c230e4-a0f2-7c2b-e053-2a91aa0a0d3e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61995-209961995-2099-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bfc87aba-495e-a37c-e053-2995a90aeb4e65c230e4-a0f2-7c2b-e053-2a91aa0a0d3e2021-04-12WarningsExact identifier
spl id: bfc87aba-495e-a37c-e053-2995a90aeb4e
spl set id: 65c230e4-a0f2-7c2b-e053-2a91aa0a0d3e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.