FDA.reportPublic FDA data

ALL WEATHER SPF 15 LIP BALM

Manufacturer
Burt's Bees
Effective date
2018-12-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:57:43

Label at a glance#

ProductALL WEATHER SPF 15 LIP BALM
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 at least every 2 hours. Reappy after 40 minutes of swimming or weating. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measuresincluding: limit time in the sun, especially from 10 a.m. ...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE 11%

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 damaged or broken skin.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure.

Reapply at least every 2 hours.

Reappy after 40 minutes of swimming or weating.

Sun Protection Measures.

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measuresincluding:

limit time in the sun, especially from 10 a.m. - 2 p.m.

wear long sleeve shirts, pants, hats and sunglasses.

Children under 6 months consult a doctor.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

beeswax, olea europaea (olive) fruit oil, theobroma cacao (cocoa) seed butter, simmondsia chinensis (jojoba) seed oil, isoamyl laurate, butyrospermum parkii (shea) butter, flavor, limnanthes alba (meadowfoam) seed oil, citrus aurantium dulcis (orange) peel wax, jojoba esters, glycine soja (soybean) oil, tocopherol, citric acid, rebaudioside A, polyhydroxystearic acid

Other Information:

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BURTS BEES

ALL WEATHER SPF 15

MOISTURIZING LIP BALM

All Weather CartonAll Weather Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
26052-036-01ALL WEATHER SPF 15 LIP BALM4.25 g in 1 TUBESTICK4.252
26052-036-02ALL WEATHER SPF 15 LIP BALM1 in 1 CARTONSTICK12
26052-036-03ALL WEATHER SPF 15 LIP BALM1 in 1 CARTONSTICK12
26052-036-04ALL WEATHER SPF 15 LIP BALM2 in 1 CARTONSTICK22
26052-036-05ALL WEATHER SPF 15 LIP BALM4 in 1 CARTONSTICK42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
26052-036ALL WEATHER SPF 15 LIP BALM (ZINC OXIDE) STICK [BURT'S BEES]2Current NDC, Legacy NDC, 5 package rows20181218_604f0949-6d6d-b3ea-e053-2a91aa0acc45.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
26052-03626052-036-01, 26052-036-02, 26052-036-03, 26052-036-04, 26052-036-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCOA BUTTER512OYT1CRRIACT
ISOAMYL LAURATEM1SLX00M3MIACT
JOJOBA OIL724GKU717MIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ZINC OXIDESOI2LOH54ZACTIB
OLIVE OIL6UYK2W1W1EIACT
YELLOW WAX2ZA36H0S2VIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
TOCOPHEROLR0ZB2556P8IACT
SOYBEAN OIL241ATL177AIACT
SHEA BUTTERK49155WL9YIACT
ORANGE PEEL WAX0U715N387CIACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
REBAUDIOSIDE AB3FUD0528FIACT

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
ALL WEATHER SPF 15 LIP BALMZINC OXIDEBurt's Bees604f0949-6d6d-b3ea-e053-2a91aa0acc452018-12-17WarningsExact identifier
ndc (package): 26052-036-03
ndc (package): 26052-036-02
ndc (package): 26052-036-04
ndc (package): 26052-036-05
ndc (package): 26052-036-01
ndc (product): 26052-036
ndc11 (package): 26052003601
ndc11 (package): 26052003605
ndc11 (package): 26052003604
ndc11 (package): 26052003602
ndc11 (package): 26052003603
spl id: 7d3cece5-17b5-404a-e053-2a91aa0a549a
spl set id: 604f0949-6d6d-b3ea-e053-2a91aa0acc45

Reported adverse events (FAERS/openFDA)#

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