FDA.reportPublic FDA data

Alba Botanica VEBL Kids Sunscreen SPF 50 Spray

Manufacturer
The Hain Celestial Group, Inc. | The Hain Celestial Group Inc.
Effective date
2021-02-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:37:50

Label at a glance#

ProductAL0038200 Alba VE Sunscreen Kids SPF50
Active ingredientOCTOCRYLENE, OCTISALATE, AVOBENZONE, HOMOSALATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Homosalate 15.0%

Ethylhexyl Methoxycinnamate 7.5%

Octocrylene 8.0%

Ethylhexyl Salicylate 5.0%

Butyl Methoxybenzoylmethane 3.0%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

  • 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 SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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.



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

can labelcan label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61995-2382-62024-01-30C16284748780-1ba0f9c33-3d6e-a910-e053-dadaa90a0b85Alba Botanica VEBL Kids Sunscreen SPF 50 Spray
61995-2382-62021-02-05C16284748780-1ba0f9c33-3d6e-a910-e053-dadaa90a0b85Alba Botanica VEBL Kids Sunscreen SPF 50 Spray
61995-2382-62021-01-29C16284748780-1ba0f9c33-3d6e-a910-e053-dadaa90a0b85Alba Botanica VEBL Kids Sunscreen SPF 50 Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61995-2382-6AL0038200 Alba VE Sunscreen Kids SPF50177 g in 1 BOTTLE, SPRAYSPRAY1773

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61995-2382AL0038200 ALBA VE SUNSCREEN KIDS SPF50 (HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE) SPRAY [THE HAIN CELESTIAL GROUP, INC.]3Legacy NDC, 1 package rows20210207_2669183c-7a5e-037e-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61995-238261995-2382-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
SOYBEAN OIL241ATL177AIACT
TERPINYL ACETATENIT9SZT3D7IACT
DIMETHYLHYDROXY FURANONE20PI8YZP7AIACT
VANILLINCHI530446XIACT
LINALOOL, (+/-)-D81QY6I88EIACT
ORANGE OILAKN3KSD11BIACT
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
GINKGO19FUJ2C58TIACT
ASIAN GINSENGCUQ3A77YXIIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
HOMOSALATEV06SV4M95SACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALCOHOL3K9958V90MIACT
AVOCADO OIL6VNO72PFC1IACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
NONANAL2L2WBY9K6TIACT
LIMONENE, (+)-GFD7C86Q1WIACT

Source Document#

Source XML

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
ba9fb048-658d-6f48-e053-2995a90a3ea92669183c-7a5e-037e-e054-00144ff88e882021-02-05WarningsExact identifier
spl id: ba9fb048-658d-6f48-e053-2995a90a3ea9
spl set id: 2669183c-7a5e-037e-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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