FDA.reportPublic FDA data

BALI BODY SPF15 BRONZE SHIMMERING TANNING GEL

Manufacturer
Bali Body Pty Ltd
Effective date
2025-06-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:03:12

Label at a glance#

ProductBALI BODY SPF15 BRONZE SHIMMERING TANNING
Active ingredientOCTOCRYLENE, OCTISALATE, AVOBENZONE
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 ageing caused by the sun.

Dosage and administration

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 protection measures including Limit time in the sun, esp...

Label contents#

Full prescribing information#

Active ingredients:

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.0%

Octisalate 5.0%

Octocrylene 7.0%

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 ageing caused by the sun.

Warnings

WARNINGS SECTION

  • For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a poison control centre right away. Please refer to balibody.com for further sun safety instructions.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 protection measures including
  • 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.

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

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
70630-0038-1BALI BODY SPF15 BRONZE SHIMMERING TANNING150 g in 1 JARGEL1503

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70630-003870630-0038-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOCHRYSIS GALBANA WHOLEH22FH39EGNIACT
BETA CAROTENE01YAE03M7JIACT
TOCOPHEROLR0ZB2556P8IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
XANTHAN GUMTTV12P4NEEIACT
STEARALKONIUM HECTORITEOLX698AH5PIACT
SOYBEAN OIL241ATL177AIACT
MICAV8A1AW0880IACT
PROPYLENE CARBONATE8D08K3S51EIACT
LEVOMENOL24WE03BX2TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARROTL56Z1JK48BIACT
OCTOCRYLENE5A68WGF6WMACTIB
PETROLATUM4T6H12BN9UIACT
OCTISALATE4X49Y0596WACTIB
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
MINERAL OILT5L8T28FGPIACT
AVOBENZONEG63QQF2NOXACTIB
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT

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
BALI BODY SPF15 BRONZE SHIMMERING TANNINGAVOBENZONE, OCTISALATE, OCTOCRYLENEBali Body Pty Ltd240d4d80-641c-ac57-e063-6394a90abe752025-06-16WarningsExact identifier
ndc (package): 70630-0038-1
ndc (product): 70630-0038
ndc11 (package): 70630003801
spl id: 37b582e9-0010-4ec6-e063-6294a90a8732
spl set id: 240d4d80-641c-ac57-e063-6394a90abe75

Reported adverse events (FAERS/openFDA)#

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