FDA.reportPublic FDA data

Alba Botanica Pure Lavender Sunscreen SPF45

Manufacturer
The Hain Celestial Group, Inc.
Effective date
2019-08-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:00:05

Label at a glance#

ProductAlba Botanica Pure Lavender Sunscreen 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 (Aqua), Homosalate, Octocrylene, Octisalate, Cetyl Alcohol, Glycerin, Avobenzone, Glyceryl Stearate SE, Dimethicone, Caprylic/Capric Triglyceride, VP/Hexadecene Copolymer, Lavandula Angustifolia (Lavender) Oil, Lavandula Hybrida Oil, Myroxylon Pereirae (Balsam Peru) Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Aloe Barbadensis Leaf Juice *, Calendula Officinalis Flower Extract *, Camellia Sinensis Leaf Extract *, Chamomilla Recutita (Matricaria) Flower Extract *, Citrus Aurantium Dulcis (Orange) Fruit Extract, Echinacea Angustifolia Extract *, Ginkgo Biloba Leaf Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract *, Panax Ginseng Root Extract, Tocopheryl Acetate, Cetearyl Alcohol, Cetearyl Olivate, Citric Acid, Polysorbate 60, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Vanillin, Xanthan Gum, Alcohol *, Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate, Limonene, Linalool.

* 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 labeltube label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61995-2093-12021-01-29C16284748780-1ba0f9c33-1eb6-a910-e053-dadaa90a0b85653418db-489d-66bd-e053-2a91aa0acb5f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61995-2093-1Alba Botanica Pure Lavender Sunscreen SPF4528 g in 1 TUBELOTION283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61995-2093ALBA BOTANICA PURE LAVENDER SUNSCREEN SPF45 (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATE) LOTION [THE HAIN CELESTIAL GROUP, INC.]3Legacy NDC, 1 package rows20190820_653418db-489d-66bd-e053-2a91aa0acb5f.zip

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61995-209361995-2093-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIMONENE, (+/-)-9MC3I34447IACT
ECHINACEA ANGUSTIFOLIAVB06AV5US8IACT
VANILLINCHI530446XIACT
LAVENDER OILZBP1YXW0H8IACT
LAVANDULA ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
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
POLYSORBATE 60CAL22UVI4MIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GINKGO19FUJ2C58TIACT
CETEARYL OLIVATE58B69Q84JOIACT
SODIUM CHLORIDE451W47IQ8XIACT
SORBITAN OLIVATEMDL271E3GRIACT
SODIUM BENZOATEOJ245FE5EUIACT
ORANGE OILAKN3KSD11BIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
LAVANDIN OIL9RES347CKGIACT
ROSEMARY OIL8LGU7VM393IACT
ASIAN GINSENGCUQ3A77YXIIACT
BALSAM PERU OILDIK0395679IACT
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
LINALOOL, (+/-)-D81QY6I88EIACT

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
907cfb96-e88d-184a-e053-2a95a90ae4d7653418db-489d-66bd-e053-2a91aa0acb5f2019-08-19WarningsExact identifier
spl id: 907cfb96-e88d-184a-e053-2a95a90ae4d7
spl set id: 653418db-489d-66bd-e053-2a91aa0acb5f

Reported adverse events (FAERS/openFDA)#

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