FDA.reportPublic FDA data

Burt's Bees Calming Day Lotion SPF30

Manufacturer
Burts Bees
Effective date
2024-12-03
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 00:40:25

Label at a glance#

ProductBurts Bees Calming Day SPF30
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (see ​Directions ​), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure Reapply ​Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly us a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in sun, especially from 10a.m.-2p.m., wear long-sleeved shirts, pants, hats and sunglasses . Children u...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 16.9%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see ​Directions​), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

​For external use only.

OTC - DO NOT USE SECTION

Do not use on broken or damaged skin.

OTC - WHEN USING SECTION

When using this product, keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swalloed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Reapply

​Sun Protection Measures

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly us a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in sun, especially from 10a.m.-2p.m., wear long-sleeved shirts, pants, hats and sunglasses . Children under 6 months: ask a doctor.

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive hear and direct sun.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

water, caprylic/capric triglyceride, glycerin, polyglyceryl-6 stearate, C13-15 alkane, pentylene glycol, mica, c15-19 alkane, silica, cetearyl nonanoate, inulin, squalane, polyhydroxystearic acid, carthamus tinctorius (safflower) seed oil, simmondsia chinensis (jojoba) seed oil, aloe barbadensis leaf juice, honey, argania spinosa kernel oil, saccharomyces ferment, beeswax, oryza sativa (rice) extract, acacia senegal gum, tocopheryl acetate, polyglyceryl-6 behenate, stearyl alcohol, cetyl alcohol, xanthan gum, glyceryl laurate, sodium PCA, sodium citrate, citric acid, sodium phytate, bisabolol, potassium sorbate, fructose, glucose, inositol, sucrose, trehalose, myristyl alcohol, arachidyl alcohol, benzoic acid, sodium benxoate, hydroxyacetophenone  

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CTNCALMINGCTNCALMING

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
26052-492-01Burts Bees Calming DaySPF301 in 1 CARTONLOTION111
26052-492-01Burts Bees Calming DaySPF3051 g in 1 TUBELOTION5111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
26052-492BURTS BEES CALMING DAY SPF30 (ZINC OXIDE) LOTION [BURTS BEES]11Current NDC, Legacy NDC, 2 package rows20241206_e406e6ba-fa6d-452d-bc29-404e2f8fcf3e.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
26052-49226052-492-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
YELLOW WAX2ZA36H0S2VIACT
ACACIA5C5403N26OIACT
SODIUM CITRATE1Q73Q2JULRIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
LEVOMENOL24WE03BX2TIACT
HEXASODIUM PHYTATEZBX50UG81VIACT
HONEYY9H1V576FHIACT
RICE GERM7N2B70SFEZIACT
ZINC OXIDESOI2LOH54ZACTIM
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
C13-15 ALKANE114P5I43UJIACT
PENTYLENE GLYCOL50C1307PZGIACT
MICAV8A1AW0880IACT
C15-19 ALKANECI87N1IM01IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CETEARYL NONANOATEF6ZWV2F361IACT
INULINJOS53KRJ01IACT
SQUALANEGW89575KF9IACT
SAFFLOWER OIL65UEH262ISIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
JOJOBA OIL724GKU717MIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ARGAN OIL4V59G5UW9XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOEV5VD430YW9IACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
XANTHAN GUMTTV12P4NEEIACT
POLYGLYCERYL-6 BEHENATE4T2L7QI313IACT
GLYCERYL LAURATEY98611C087IACT

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
Burts Bees Calming Day SPF30ZINC OXIDEBurts Beese406e6ba-fa6d-452d-bc29-404e2f8fcf3e2024-12-03WarningsExact identifier
ndc (package): 26052-492-01
ndc (product): 26052-492
ndc11 (package): 26052049201
spl id: 2863a3cd-e4d4-a6e5-e063-6394a90a07dc
spl set id: e406e6ba-fa6d-452d-bc29-404e2f8fcf3e

Reported adverse events (FAERS/openFDA)#

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