FDA.reportPublic FDA data

Alba Lip Care Sunblock SPF 25

Manufacturer
The Hain Celestial Group, Inc.
Effective date
2010-07-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:25:21

Label at a glance#

ProductAlba Lip Care Sunblock SPF 25
Active ingredientOctocrylene, Octinoxate, Zinc Oxide, Octisalate
Label structure5 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS

Octocrylene      10.0%

Ethylhexyl Methoxycinnamate    7.5%

Zinc Oxide  3.9%

Ethylhexyl Salicilate    1.0%


INDICATIONS & USAGE SECTION

                             USES

  •     Helps prevent sunburns
  •     Higher SPF gives more sunburn protection
  •     Apply liberally as needed 15 to 20 minutes before sun exposure
  •      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 cartonimage of carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61995-2394-12019-10-21C16284748780-1956f9ecf-d0da-621f-e053-dbdaa90a74adDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61995-2394-1Alba Lip Care Sunblock SPF 251 in 1 CARTONCREAM11
61995-2394-1Alba Lip Care Sunblock SPF 254.2 g in 1 CANISTERCREAM4.21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61995-2394ALBA LIP CARE SUNBLOCK SPF 25 ( OCTOCRYLENE, ETHYLHEXYL METHOXYCINNAMATE, ZINC OXIDE, ETHYLHEXYL SALICILATE ) CREAM [THE HAIN CELESTIAL GROUP, INC.]1Legacy NDC, 2 package rows20100728_e508eb29-ba3c-420d-83f7-82c10bc15c44.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD511
OctisalateACTIVE INGREDIENT4X49Y0596W1
OctocryleneACTIVE INGREDIENT5A68WGF6WM1
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
OctinoxateACTIVE MOIETY4Y5P7MUD511
OctisalateACTIVE MOIETY4X49Y0596W1
OctocryleneACTIVE MOIETY5A68WGF6WM1
Zinc CationACTIVE MOIETY13S1S8SF371

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61995-239461995-2394-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
Octocrylene5A68WGF6WMACTIB
Octinoxate4Y5P7MUD51ACTIB
Zinc OxideSOI2LOH54ZACTIB
Octisalate4X49Y0596WACTIB

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
c330b16e-974e-4edc-8f12-3a4237223b21e508eb29-ba3c-420d-83f7-82c10bc15c442010-07-26WarningsExact identifier
spl id: c330b16e-974e-4edc-8f12-3a4237223b21
spl set id: e508eb29-ba3c-420d-83f7-82c10bc15c44

Reported adverse events (FAERS/openFDA)#

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