FDA.reportPublic FDA data

Bali Body SPF 15 Pineapple Tanning Oil

Manufacturer
Bali Body Pty Ltd
Effective date
2019-02-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:58:40

Label at a glance#

ProductBali Body SPF 15 Pineapple Tanning Oil
Active ingredientOCTOCRYLENE, OCTINOXATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 2.8%

Octocrylene 2.8%

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PURPOSE SECTION

A tanning and body oil.

Provides SPF 15 protection.

INDICATIONS & USAGE SECTION

Shake well before use. Apply liberaly 15 minutes before sun exposure.

Children under 6 months: Ask a doctor.

Reapply every 2 hours.

Use water-resistant sunscreen if swimming or sweating.

Store in a cool dry place.

INACTIVE INGREDIENT SECTION

  • Grape seed oil;
  • Coconut oil;
  • Soybean oil;
  • Sweet almond oil;
  • Pineapple; and
  • Vitamin E.

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 ben shown only to help prevent sunburn, not skin cancer or early skin aging.

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.

Always wear a hat, protective clothing and sunglasses.

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BB 15 3BB 15 3

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70630-1804-12021-01-29C16284748780-1ba0f9c33-42f3-a910-e053-dadaa90a0b85Bali Body Pineapple Tanning Oil SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70630-1804-1Bali Body SPF 15 Pineapple Tanning Oil100 mL in 1 BOTTLEOIL1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70630-1804BALI BODY SPF 15 PINEAPPLE TANNING OIL (OCTINOXATE, OCTOCRYLENE CREAM) OIL [BALI BODY PTY LTD]2Legacy NDC, 1 package rows20190301_70e5e4d0-6831-78e9-e053-2995a90a6820.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70630-180470630-1804-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTOCRYLENE5A68WGF6WMACTIB
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
OCTINOXATE4Y5P7MUD51ACTIB
SOYBEAN OIL241ATL177AIACT
PINEAPPLE2A88ZO081OIACT
COCONUT OILQ9L0O73W7LIACT
ALMOND OIL66YXD4DKO9IACT
GRAPE SEED OIL930MLC8XGGIACT

Source Document#

Source XML · Source PDF

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
82fa9d55-951b-6c96-e053-2a91aa0a717770e5e4d0-6831-78e9-e053-2995a90a68202019-02-28WarningsExact identifier
spl id: 82fa9d55-951b-6c96-e053-2a91aa0a7177
spl set id: 70e5e4d0-6831-78e9-e053-2995a90a6820

Reported adverse events (FAERS/openFDA)#

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