FDA.reportPublic FDA data

BaliBody SPF15 Bronze Shimmering Tanning Gel

Manufacturer
Baxter Laboratories Pty. Ltd.
Effective date
2024-12-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:53:44

Label at a glance#

ProductBaliBody SPF15 Bronze Shimmering Tanning Gel
Active ingredientOCTOCRYLENE, AVOBENZONE, OCTISALATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Purpose:

Avobenzone 2.0%, Octyl Salicylate 5.0%, Octocrylene 7.0% Sunscreen

OTC - PURPOSE SECTION

Uses

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs.

WARNINGS SECTION

Warnings

For external use only. Do not use on damaged or broken skin. When using this product keep ou tof eyes. Rinse with water to remove. If product is swallowed, get medical help or contact a poison control center right away. Please refer to balibodyco.com for further sun safety instructions.

DOSAGE & ADMINISTRATION SECTION

Directions

Apply liberally 15 minutes before sun exposure. Re-apply your BB at least every 2 hours. Wear 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 ageing. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protective measures including. Limit time in the sun, especially from 10am-2pm. Wear long sleeved shirts, parts, hats and sunglasses. Children under 6 months of age: Ask a doctor.

INACTIVE INGREDIENT SECTION

Inactive ingredients: Petrolatum, Caprylic/Capric Triglyceride, Mineral Oil, C12-15 Alkyl Benzoate, Sorbitan Stearate, Propylene Glycol, Mica, Stearalkonium Hectorite, Iron Oxides, Xanthan Gum, Triethanolamine, Propylene Carbonate, Glycine Soja (Soybean) Oil, Fragrance/Parfum, Bisabolol, Beta-Carolene, Daucus Carota Sativa (Carrot) Root Extract, Tocopherol, BHT, Tocopheryl Acetate, Isochrysis Galbana Extract.

OTHER SAFETY INFORMATION

Other information: Protect this product from excessive heat and direct sun. Report serious adverse events to: AMS Fullfilment 29010 Commerce Drive, Valencia CA 91355.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BaliBody

SPF 15 Bronze Shimmering Tanning Gel

150g 5.07fl.oz

Shimmering Tanning Gel SPF 15Shimmering Tanning Gel SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70157-024-01BaliBody SPF15 Bronze Shimmering Tanning Gel150 g in 1 JARGEL1501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70157-024BALIBODY SPF15 BRONZE SHIMMERING TANNING GEL (AVOBENZONE, OCTISALATE, OCTOCRYLENE) GEL [BAXTER LABORATORIES PTY. LTD.]1Current NDC, 1 package rows20250129_28660ce2-6805-41f3-e063-6394a90af45d.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70157-02470157-024-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTOCRYLENE5A68WGF6WMACTIB
IRON OXIDES1K09F3G675IACT
MICAV8A1AW0880IACT
ISOCHRYSIS GALBANA WHOLEH22FH39EGNIACT
STEARALKONIUM HECTORITEOLX698AH5PIACT
AVOBENZONEG63QQF2NOXACTIB
MINERAL OILT5L8T28FGPIACT
TRIETHANOLAMINE9O3K93S3TKIACT
BETA-CAROTENE01YAE03M7JIACT
BHT1P9D0Z171KIACT
BISABOLOL24WE03BX2TIACT
OCTISALATE4X49Y0596WACTIB
SORBITAN STEARATENVZ4I0H58XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
XANTHAN GUMTTV12P4NEEIACT
TOCOPHEROLR0ZB2556P8IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PETROLATUM4T6H12BN9UIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
PROPYLENE CARBONATE8D08K3S51EIACT
GLYCINE SOJA (SOYBEAN) OIL241ATL177AIACT
CARROTL56Z1JK48BIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT

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
BaliBody SPF15 Bronze Shimmering Tanning GelAVOBENZONE, OCTISALATE, OCTOCRYLENEBaxter Laboratories Pty. Ltd.28660ce2-6805-41f3-e063-6394a90af45d2024-12-03WarningsExact identifier
ndc (package): 70157-024-01
ndc (product): 70157-024
ndc11 (package): 70157002401
spl id: 28660ce2-6806-41f3-e063-6394a90af45d
spl set id: 28660ce2-6805-41f3-e063-6394a90af45d

Reported adverse events (FAERS/openFDA)#

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