FDA.reportPublic FDA data

Alba Botanica Hawaiian Green Tea SPF 45 Lotion

Manufacturer
The Hain Celestial Group, Inc.
Effective date
2019-09-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:00:11

Label at a glance#

ProductAlba Botanica HW Sunscreen Green Tea 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%

Ethylhexyl 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, Glycerin, Glyceryl Stearate SE, Cetyl Alcohol, Dimethicone, Cetearyl Alcohol, VP/Hexadecene Copolymer, Caprylic/Capric Triglyceride, , Aloe Barbadensis Leaf Juice(1), Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Calendula Officinalis Flower Extract (1),Citrus Aurantium Dulcis ((Orange) Peel Oil, Lavandula Angustifolia (Lavender) Extract (1), Ginkgo Biloba Leaf Extract, Cetearyl Alcohol, Cetearyl Olivate, Citric Acid, Polysorbate 60, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Tocopheryl Acetate, Triethyl Citrate, Xanthan Gum, Alcohol (1), Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate.

(1) Certified Organicf 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

tube label 4oztube label 4oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61995-2011-42021-01-29C16284748780-1ba0f9c33-13e3-a910-e053-dadaa90a0b85Alba Botanica Hawaiian Green Tea SPF 45 Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61995-2011-4Alba Botanica HW Sunscreen Green Tea SPF45113 g in 1 TUBELOTION1134

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61995-2011ALBA BOTANICA HW SUNSCREEN GREEN TEA SPF45 (AVOBENZONE,HOMOSALATE, OCTOCRYLENE,OCTYL SALICYLATE) LOTION [THE HAIN CELESTIAL GROUP, INC.]4Legacy NDC, 1 package rows20190904_6289bfcd-e943-3d6e-e053-2991aa0aadd2.zip

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61995-201161995-2011-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
BENZYL ALCOHOLLKG8494WBHIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CETYL ALCOHOL936JST6JCNIACT
DIMETHICONE92RU3N3Y1OIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CHAMOMILEFGL3685T2XIACT
XANTHAN GUMTTV12P4NEEIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
LAVANDULA ANGUSTIFOLIA FLOWERING TOP9YT4B71U8PIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
POLYSORBATE 60CAL22UVI4MIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GINKGO19FUJ2C58TIACT
CETEARYL OLIVATE58B69Q84JOIACT
SODIUM CHLORIDE451W47IQ8XIACT
SORBITAN OLIVATEMDL271E3GRIACT
SODIUM BENZOATEOJ245FE5EUIACT
ORANGE OILAKN3KSD11BIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB

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
91a9e7b7-4cf6-8e17-e053-2995a90a71ce6289bfcd-e943-3d6e-e053-2991aa0aadd22019-09-03WarningsExact identifier
spl id: 91a9e7b7-4cf6-8e17-e053-2995a90a71ce
spl set id: 6289bfcd-e943-3d6e-e053-2991aa0aadd2

Reported adverse events (FAERS/openFDA)#

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