FDA.reportPublic FDA data

Alba Botanica Sensitive Mineral SPF 50

Manufacturer
The Hain Celestial Group, Inc.
Effective date
2025-11-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:18:31

Label at a glance#

ProductAlba Botanica Sensitive Mineral SPF 50
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 24.1% (w/w)

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Reapply: ● after 80 minutes of swimming or sweating ● immediately after towel drying ● at least every 2 hours. Children under 6 months of age: ask a doctor.

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), Caprylic/Capric Triglyceride, Ethylhexyl Olivate, Butyloctyl Salicylate, Isoamyl Laurate, Glyceryl Stearate, Niacinamide, VP/Hexadecene Copolymer, Tocopheryl Acetate, Glycerin, Polyhydroxystearic Acid, Potassium Cetyl Phosphate, Sodium Phytate, Squalane, Triethoxycaprylylsilane, Xanthan Gum, Alcohol, Ethylhexylglycerin, Phenoxyethanol

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.

Alba Botanical Sensitive Mineral sunscreen SPF 50

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabelLabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130724742006563GTIN-13: 0724742006563
EAN-13: 0724742006563
GTIN-12: 724742006563
UPC-A: 724742006563
GTIN storage (14 digits): 00724742006563		AL00656 Sensitive mineral SPF50.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61995-2036-1Alba Botanica Sensitive Mineral SPF 5059 g in 1 TUBELOTION592
61995-2036-2Alba Botanica Sensitive Mineral SPF 5089 g in 1 TUBELOTION892
61995-2036-3Alba Botanica Sensitive Mineral SPF 50113 g in 1 TUBELOTION1132

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61995-203661995-2036-1, 61995-2036-2, 61995-2036-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ETHYLHEXYL OLIVATEHTC7G3S2PVIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
GLYCERYL STEARATE230OU9XXE4IACT
ISOAMYL LAURATEM1SLX00M3MIACT
NIACINAMIDE25X51I8RD4IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
SQUALANEGW89575KF9IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ZINC OXIDESOI2LOH54ZACTIB
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERINPDC6A3C0OXIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
XANTHAN GUMTTV12P4NEEIACT
ALCOHOL3K9958V90MIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
SODIUM PHYTATE88496G1ERLIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT

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
Alba Botanica Sensitive Mineral SPF 50ZINC OXIDEThe Hain Celestial Group, Inc.4484b16f-f29a-60cc-e063-6294a90a2b9d2025-11-26WarningsExact identifier
ndc (package): 61995-2036-3
ndc (package): 61995-2036-2
ndc (package): 61995-2036-1
ndc (product): 61995-2036
ndc11 (package): 61995203602
ndc11 (package): 61995203601
ndc11 (package): 61995203603
spl id: 44865233-8c1f-3601-e063-6294a90a116b
spl set id: 4484b16f-f29a-60cc-e063-6294a90a2b9d

Reported adverse events (FAERS/openFDA)#

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