FDA.reportPublic FDA data

Bondi Sands Toasted Coconut Lip Balm with SPF 50 Sunscreen

Manufacturer
BONDI SANDS (USA) INC.
Effective date
2024-11-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:35:00

Label at a glance#

ProductBondi Sands Toasted Coconut Lip Balm with SPF 50 Sunscreen
Active ingredientAVOBENZONE, OCTOCRYLENE, HOMOSALATE
Label structure10 sections

Indications and uses

Helps prevent sunburn Higher SPF gives more sunburn protection

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. 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 value of 15 or higher and other sun protection measures including: Limit time in the sun, especial...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%, Homosalate 8%, Octocrylene 4%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or ealy skin aging.

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash or irritation develops and lasts.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • 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 value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m.- 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months: Ask a doctor.

Other information

OTHER SAFETY INFORMATION

  • Protect the product in this container from excessive heat and direct sun.
  • You may report a serious adverse reaction to 888-266-0772; Monday – Friday, 9 am – 5 pm.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Ricinus Communis (Castor) Seed Oil, Octyldodecanol, Synthetic Beeswax, Microcrystalline Wax/Cera Microcristallina/Cire microcrystalline, Hydrogenated Polydecene, Cetyl Palmitate, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Cocoglycerides, Simmondsia Chinensis (Jojoba) Seed Oil, Flavor/Aroma, Triacontanyl PVP, PEG-30 Dipolyhydroxystearate, Tocopheryl Acetate, Saccharin, Anise Alcohol.

Questions?

OTC - QUESTIONS SECTION

888-266-0772 or visit bondisands.com

Company Information

SPL UNCLASSIFIED SECTION

Made in Australia.

Distributed by Bondi Sands USA

Wilmingon, 19808, DE.

bondisands.com

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bondi sands

The Australian tan

LIP BALM

with

SPF 50

TOASTED COCONUT

SUNSCREEN

LIP CARE

Australian Made

Net wt. 0.35 OZ. (10g)

lip balmlip balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79950-002-01Bondi Sands Toasted Coconut Lip Balm with SPF 50 Sunscreen10 g in 1 TUBE, WITH APPLICATORLIPSTICK103
79950-002-01Bondi Sands Toasted Coconut Lip Balm with SPF 50 Sunscreen1 in 1 CARTONLIPSTICK13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79950-002BONDI SANDS TOASTED COCONUT LIP BALM WITH SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTOCRYLENE) LIPSTICK [BONDI SANDS (USA) INC.]3Current NDC, Legacy NDC, 2 package rows20241108_acb8513e-723b-b7d6-e053-2995a90aed52.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79950-00279950-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROGENATED POLYDECENE (1500 CST)4YI0729529IACT
CASTOR OILD5340Y2I9GIACT
AVOBENZONEG63QQF2NOXACTIB
OCTYLDODECANOL461N1O614YIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
CETYL PALMITATE5ZA2S6B08XIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
COCO-GLYCERIDESISE9I7DNUGIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SHEA BUTTERK49155WL9YIACT
JOJOBA OIL724GKU717MIACT
TRICONTANYL POVIDONEN0SS3Q238DIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
SACCHARINFST467XS7DIACT
ANISYL ALCOHOL7N6XGV3U49IACT
YELLOW WAX2ZA36H0S2VIACT
OCTOCRYLENE5A68WGF6WMACTIB
HOMOSALATEV06SV4M95SACTIB

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
Bondi Sands Toasted Coconut Lip Balm with SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENEBONDI SANDS (USA) INC.acb8513e-723b-b7d6-e053-2995a90aed522024-11-06WarningsExact identifier
ndc (package): 79950-002-01
ndc (product): 79950-002
ndc11 (package): 79950000201
spl id: 26436451-e1db-ad8f-e063-6394a90a0f38
spl set id: acb8513e-723b-b7d6-e053-2995a90aed52

Reported adverse events (FAERS/openFDA)#

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