FDA.reportPublic FDA data

Alba Sunscreen Lip Balm SPF 25

Manufacturer
The Hain Celestial Group, Inc.
Effective date
2023-12-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:03:20

Label at a glance#

ProductAlba Sunscreen Lip Balm SPF 25
Active ingredientOCTOCRYLENE, ZINC OXIDE, OCTISALATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS

Zinc Oxide 10%

Octocrylene 10%

Octisalate 5%

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

WARNINGS SECTION

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

Made in the U.S.A.

INACTIVE INGREDIENT SECTION

Olea Europaea (Olive) Fruit Oil (1), Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil (1), Euphorbia Cerifera (Candelilla) Wax, Theobroma Cacao (Cocoa) Seed Butter (1), Jojoba Esters, Jojoba Esters/Helianthus Annuus (Sunflower) Seed Wax/Acacia Decurrens Flower Wax/Polyglycerin-3, Flavor, Glycerin (1), Copernicia Cerifera (Carnauba) Wax, Butyrospermum Parkii (Shea) Butter (1), Helianthus Annuus (Sunflower) Seed Oil, Aloe Barbadensis Leaf Juice (1), Chamomilla Recutita (Matricaria) Flower Extract, Echinacea Angustifolia Leaf Extract (1), Hydrastis Canadensis (Goldenseal) Root Extract (1), Glycyrrhiza Glabra (Licorice) Root Extract (1), Symphytum Officinale Leaf Extract (1), Tocopherol

(1)Certified Organic Ingredient

DOSAGE & ADMINISTRATION SECTION

Sunscreen Lip Balm

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

OTC - PURPOSE SECTION

Sunscreen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61995-3037-12025-01-30C16284748780-12cef2736-abfd-d83d-e063-dadaa90ab31fAL00394-05 Alba Sun Lip Balm SPF 25 14680-1 /B12294

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61995-3037-1Alba Sunscreen Lip Balm SPF 251 in 1 CARTONSTICK11
61995-3037-1Alba Sunscreen Lip Balm SPF 254.2 g in 1 CANISTERSTICK4.21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61995-3037ALBA SUNSCREEN LIP BALM SPF 25 (ZINC OXIDE, OCTOCRYLENE, OCTISALATE) STICK [THE HAIN CELESTIAL GROUP, INC.]12 package rows20231207_0bdea2fb-70c6-620c-e063-6394a90a2a3b.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61995-303761995-3037-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS)CH428W5O62IACT
ACACIA DECURRENS FLOWER WAXAU6XZE9IY9IACT
POLYGLYCERIN-34A0NCJ6RD6IACT
ECHINACEA ANGUSTIFOLIA LEAFFS7G8S6PJ8IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
HYDROGENATED OLIVE OIL53839415GIIACT
GLYCERINPDC6A3C0OXIACT
SHEA BUTTERK49155WL9YIACT
SUNFLOWER SEED OIL GLYCERETH-8 ESTERS358X17CAT0IACT
COCOA BUTTER512OYT1CRRIACT
GLYCYRRHIZA GLABRA WHOLEM1F96IE0ZCIACT
MATRICARIA CHAMOMILLAG0R4UBI2ZZIACT
SUNFLOWER SEEDR9N3379M4ZIACT
HYDRASTIS CANADENSIS WHOLER763EBH88TIACT
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDEFJ1H6M2JG9IACT
COCONUT OILQ9L0O73W7LIACT
SYMPHYTUM OFFICINALE WHOLEH8FJJ6KX5YIACT
OCTOCRYLENE5A68WGF6WMACTIB
ZINC OXIDESOI2LOH54ZACTIB
OCTISALATE4X49Y0596WACTIB
CANDELILLA WAXWL0328HX19IACT
CARNAUBA WAXR12CBM0EIZIACT

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
0bde7fd6-c1c6-eae8-e063-6294a90a9d0f0bdea2fb-70c6-620c-e063-6394a90a2a3b2023-12-06WarningsExact identifier
spl id: 0bde7fd6-c1c6-eae8-e063-6294a90a9d0f
spl set id: 0bdea2fb-70c6-620c-e063-6394a90a2a3b

Reported adverse events (FAERS/openFDA)#

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