FDA.reportPublic FDA data

BBW SPF 35 Natural Lip Balm

Manufacturer
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#

ProductBBW SPF 35 Pink Dream Lip Balm
Active ingredientHOMOSALATE, OCTISALATE, AVOBENZONE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.5%

Homosalate 10%

Octisalate 5%

OTC - PURPOSE SECTION

Avobenzone - Sunscreen

Homosalate - Sunscreen

Octisalate - Sunscreen

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

WARNINGS SECTION

For external use only

Do not use on domaged or broken skin

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

Sop use and ask a doctor if rash occurs

INSTRUCTIONS FOR USE SECTION

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

OTHER SAFETY INFORMATION

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

Wear long sleeved shirts, pants, hats and sunglasses

Children under 6 months of age: ask a doctor

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 skin 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

Summer dream drug facts boxSummer dream drug facts boxBerry drug facts boxBerry drug facts boxNatural drug facts boxNatural drug facts box

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51514-0365-1BBW SPF 35 Natural Lip Balm4 g in 1 TUBESTICK41
51514-0366-1BBW SPF 35 Berry Lip Balm4 g in 1 TUBESTICK41
51514-0367-1BBW SPF 35 Pink Dream Lip Balm4 g in 1 TUBESTICK41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51514-0365BBW SPF 35 PINK DREAM LIP BALM STICK BBW SPF 35 BERRY LIP BALM STICK BBW SPF 35 NATURAL LIP BALM STICK [AUTUMN HARP]1Current NDC, 1 package rows20240123_0f8b024c-c481-951b-e063-6394a90ac63c.zip
51514-0366BBW SPF 35 PINK DREAM LIP BALM STICK BBW SPF 35 BERRY LIP BALM STICK BBW SPF 35 NATURAL LIP BALM STICK [AUTUMN HARP]1Current NDC, 1 package rows20240123_0f8b024c-c481-951b-e063-6394a90ac63c.zip
51514-0367BBW SPF 35 PINK DREAM LIP BALM STICK BBW SPF 35 BERRY LIP BALM STICK BBW SPF 35 NATURAL LIP BALM STICK [AUTUMN HARP]1Current NDC, 1 package rows20240123_0f8b024c-c481-951b-e063-6394a90ac63c.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
51514-036551514-0365-1
51514-036651514-0366-1
51514-036751514-0367-1

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 79 matching rows.

Name, UNII, Kind table
NameUNIIKind
YELLOW WAX2ZA36H0S2VIACT
SUNFLOWER OIL3W1JG795YIIACT
HYDROGENATED COCO-GLYCERIDESXDD37N2GPRIACT
LAUROYL LYSINE113171Q70BIACT
BENZYL ALCOHOLLKG8494WBHIACT
HOMOSALATEV06SV4M95SACTIB
CASTOR OILD5340Y2I9GIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
MICAV8A1AW0880IACT
SOYBEAN OIL241ATL177AIACT
OCTISALATE4X49Y0596WACTIB
CANDELILLA WAXWL0328HX19IACT
SHEA BUTTERK49155WL9YIACT
COCOA BUTTER512OYT1CRRIACT
GARCINIA INDICA SEED BUTTERUS2H3D7800IACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
BENZYL SALICYLATEWAO5MNK9TUIACT
CARNAUBA WAXR12CBM0EIZIACT
BENZYL BENZOATEN863NB338GIACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
ANISE OIL6Y89129C8HIACT
AVOBENZONEG63QQF2NOXACTIB
COCONUT OILQ9L0O73W7LIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FD&C YELLOW NO. 5 ALUMINUM LAKEJQ6BLH9FR7IACT
YELLOW WAX2ZA36H0S2VIACT
SUNFLOWER OIL3W1JG795YIIACT
HYDROGENATED COCO-GLYCERIDESXDD37N2GPRIACT
LAUROYL LYSINE113171Q70BIACT
BENZYL ALCOHOLLKG8494WBHIACT
HOMOSALATEV06SV4M95SACTIB
CASTOR OILD5340Y2I9GIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
MICAV8A1AW0880IACT
SOYBEAN OIL241ATL177AIACT
OCTISALATE4X49Y0596WACTIB

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
BBW SPF 35 Natural Lip BalmBBW SPF 35 NATURAL LIP BALMAutumn Harp0f8b024c-c481-951b-e063-6394a90ac63c2024-01-22WarningsExact identifier
ndc (package): 51514-0366-1
ndc (package): 51514-0367-1
ndc (package): 51514-0365-1
ndc (product): 51514-0367
ndc (product): 51514-0366
ndc (product): 51514-0365
ndc11 (package): 51514036601
ndc11 (package): 51514036501
ndc11 (package): 51514036701
spl id: 0f8b024c-c482-951b-e063-6394a90ac63c
spl set id: 0f8b024c-c481-951b-e063-6394a90ac63c

Reported adverse events (FAERS/openFDA)#

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