FDA.reportPublic FDA data

Bath and Body Works SPF 35 Berry Lip Balm

Manufacturer
Bath and Body Works, Inc. | Autumn Harp
Effective date
2024-01-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:07:40

Label at a glance#

ProductBath and Body Works SPF 35 Summer Crush Lip Balm
Active ingredientHOMOSALATE, OCTISALATE, AVOBENZONE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Avobenzone - 2.5%

Octisalate - 5%

Homosalate - 10%

OTC - PURPOSE SECTION

Avobenzone - Sunscreen

Octisalate - Sunscreen

Homosalate - Sunscreen

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposire. Reapply:

  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours

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 rash occurs

INSTRUCTIONS FOR USE SECTION

Limit time in the sun, especially from 10am-2pm

Wear long sleeved shirts, pants, hats and sunglasses

Childresn under 6 months of age, ask doctor

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

Natural Inactive Ingredients: Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Beeswax, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Hydrogenated Coco-Glycerides, Copernicia Cerifera (Carnauba) Wax, Garcinia Indica Seed Butter, Flavor, Limnanthes Alba (Meadowfoam) Seed Oil, Benzyl Benzoate, Mica, Tocopherol, Stevia Rebaudiana Leaf/Stem Extract, Lauroyl Lysine, Glycine Soja (Soybean) Oil, Benzyl Alcohol, Benzyl Salicylate.

Berry Inactive Ingredients: Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Beeswax, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Hydrogenated Coco-Glycerides, Copernicia Cerifera (Carnauba) Wax, Garcinia Indica Seed Butter, Flavor, Limnanthes Alba (Meadowfoam) Seed Oil, Benzyl Benzoate, Mica, Red 33 Lake (CI 17200), Red 7 Lake (CI 15850), Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140), Tocopherol, Stevia Rebaudiana Leaf/Stem Extract, Lauroyl Lysine, Glycine Soja (Soybean) Oil, Benzyl Alcohol, Benzyl Salicylate.

Summer Crush Inactive Ingredients: Cocos Nucifera (Coconut) Oil, Beeswax, Ricinus Communis (Castor) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Hydrogenated Coco-Glycerides, Copernicia Cerifera (Carnauba) Wax, Garcinia Indica Seed Butter, Titanium Dioxide (CI 77891), Flavor, Limnanthes Alba (Meadowfoam) Seed Oil, Benzyl Benzoate, Mica, Iron Oxide (CI 77492), Iron Oxides (CI 77491), Red 7 Lake (CI 15850), Tocopherol, Iron Oxides (CI77499), Stevia Rebaudiana Leaf/Stem Extract, Lauroyl Lysine, Glycine Soja (Soybean) Oil, Benzyl Alcohol, Benzyl Salicylate.

OTC - QUESTIONS SECTION

1-800-395-1001

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 aging caused by the sun

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Natural drug facts boxNatural drug facts boxBerry drug facts boxBerry drug facts boxSummer dream drug facts boxSummer dream drug facts box

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62670-6607-1Bath and Body Works SPF 35 Natural Lip Balm4 g in 1 TUBESTICK41
62670-6608-1Bath and Body Works SPF 35 Berry Lip Balm4 g in 1 TUBESTICK41
62670-6609-1Bath and Body Works SPF 35 Summer Crush Lip Balm4 g in 1 TUBESTICK41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62670-6607BATH AND BODY WORKS SPF 35 SUMMER CRUSH LIP BALM STICK BATH AND BODY WORKS SPF 35 NATURAL LIP BALM STICK BATH AND BODY WORKS SPF 35 BERRY LIP BALM STICK [BATH AND BODY WORKS, INC.]1Current NDC, 1 package rows20240123_0f8dab80-c84f-ffbd-e063-6294a90a317e.zip
62670-6608BATH AND BODY WORKS SPF 35 SUMMER CRUSH LIP BALM STICK BATH AND BODY WORKS SPF 35 NATURAL LIP BALM STICK BATH AND BODY WORKS SPF 35 BERRY LIP BALM STICK [BATH AND BODY WORKS, INC.]1Current NDC, 1 package rows20240123_0f8dab80-c84f-ffbd-e063-6294a90a317e.zip
62670-6609BATH AND BODY WORKS SPF 35 SUMMER CRUSH LIP BALM STICK BATH AND BODY WORKS SPF 35 NATURAL LIP BALM STICK BATH AND BODY WORKS SPF 35 BERRY LIP BALM STICK [BATH AND BODY WORKS, INC.]1Current NDC, 1 package rows20240123_0f8dab80-c84f-ffbd-e063-6294a90a317e.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62670-660762670-6607-1
62670-660862670-6608-1
62670-660962670-6609-1

Ingredients#

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

DailyMed ingredient rows page 1 of 3 · 81 matching rows.

Name, UNII, Kind table
NameUNIIKind
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
MICAV8A1AW0880IACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
SOYBEAN OIL241ATL177AIACT
BENZYL BENZOATEN863NB338GIACT
BENZYL SALICYLATEWAO5MNK9TUIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
D&C RED NO. 7ECW0LZ41X8IACT
GARCINIA INDICA SEED BUTTERUS2H3D7800IACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
SHEA BUTTERK49155WL9YIACT
BENZYL ALCOHOLLKG8494WBHIACT
ANISE OIL6Y89129C8HIACT
SUNFLOWER OIL3W1JG795YIIACT
LAUROYL LYSINE113171Q70BIACT
COCOA BUTTER512OYT1CRRIACT
HYDROGENATED COCO-GLYCERIDESXDD37N2GPRIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
COCONUT OILQ9L0O73W7LIACT
CANDELILLA WAXWL0328HX19IACT
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
CASTOR OILD5340Y2I9GIACT
YELLOW WAX2ZA36H0S2VIACT
CARNAUBA WAXR12CBM0EIZIACT
GARCINIA INDICA SEED BUTTERUS2H3D7800IACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
SHEA BUTTERK49155WL9YIACT
BENZYL ALCOHOLLKG8494WBHIACT
ANISE OIL6Y89129C8HIACT
SUNFLOWER OIL3W1JG795YIIACT
LAUROYL LYSINE113171Q70BIACT
BENZYL BENZOATEN863NB338GIACT
BENZYL SALICYLATEWAO5MNK9TUIACT
COCOA BUTTER512OYT1CRRIACT
HYDROGENATED COCO-GLYCERIDESXDD37N2GPRIACT

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
Bath and Body Works SPF 35 Natural Lip BalmBATH AND BODY WORKS SPF 35 NATURAL LIP BALMBath and Body Works, Inc.0f8dab80-c84f-ffbd-e063-6294a90a317e2024-01-22WarningsExact identifier
ndc (package): 62670-6608-1
ndc (package): 62670-6609-1
ndc (package): 62670-6607-1
ndc (product): 62670-6609
ndc (product): 62670-6607
ndc (product): 62670-6608
ndc11 (package): 62670660901
ndc11 (package): 62670660701
ndc11 (package): 62670660801
spl id: 0f8dab80-c850-ffbd-e063-6294a90a317e
spl set id: 0f8dab80-c84f-ffbd-e063-6294a90a317e

Reported adverse events (FAERS/openFDA)#

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