FDA.reportPublic FDA data

Alba Hawaiian Coconut Siscreen SPF 15

Manufacturer
The Hain Celestial Group, Inc.
Effective date
2010-07-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:25:14

Label at a glance#

ProductAlba Hawaiian Coconut Siscreen SPF 15
Active ingredientHomosalate, Octisalate, Octocrylene
Label structure5 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS

Homosalate       10.0%

Ethylhexyl Salicilate    5.0%

Octocrylene      3.0%

INDICATIONS & USAGE SECTION

USES

  •     Helps prevent sunburns
  •     Higher SPF gives more sunburn protection
  •     Apply liberally  before sun exposure as needed
  •      Reapply as needed or after swimming, perspiring or towel drying
  •      Children under 6 months of age: ask doctor

WARNINGS SECTION

WARNINGS

For external use only. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact Poison Center right away.

OTC - QUESTIONS SECTION

QUESTIONS?

Call (888) 659-7730 or visit www.AlbaBotanica.com

100% Vegetarian Ingredients

No Animal Testing

Alba Botanica

The Hain Celestial Group, Inc.

Melville, NY 11747

Made in the U.S.A.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of bottle labelimage of bottle label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61995-2831-42019-10-21C16284748780-1956f9ecf-bc1f-621f-e053-dbdaa90a74adDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61995-2831-4Alba Hawaiian Coconut Siscreen SPF 15133 g in 1 BOTTLECREAM1331

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61995-2831ALBA HAWAIIAN COCONUT SISCREEN SPF 15 (HOMOSALATE, ETHYLHEXYL SALICYLATE, OCTOCRYLENE) CREAM [THE HAIN CELESTIAL GROUP, INC.]1Legacy NDC, 1 package rows20100716_0eb10ddf-412d-40d2-a295-b4a0a476c50a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HomosalateACTIVE INGREDIENTV06SV4M95S1
OctisalateACTIVE INGREDIENT4X49Y0596W1
OctocryleneACTIVE INGREDIENT5A68WGF6WM1
HomosalateACTIVE MOIETYV06SV4M95S1
OctisalateACTIVE MOIETY4X49Y0596W1
OctocryleneACTIVE MOIETY5A68WGF6WM1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61995-283161995-2831-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
HomosalateV06SV4M95SACTIB
Octisalate4X49Y0596WACTIB
Octocrylene5A68WGF6WMACTIB

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
85846e1f-75fa-47bd-9604-ee15b6e957230eb10ddf-412d-40d2-a295-b4a0a476c50a2010-07-14WarningsExact identifier
spl id: 85846e1f-75fa-47bd-9604-ee15b6e95723
spl set id: 0eb10ddf-412d-40d2-a295-b4a0a476c50a

Reported adverse events (FAERS/openFDA)#

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