FDA.reportPublic FDA data

Bali Body Pineapple Tanning Oil SPF15

Manufacturer
Bali Body Pty Ltd
Effective date
2024-10-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:27:44

Label at a glance#

ProductBali Body Pineapple Tanning Oil SPF15
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

Shake well before use. Apply liberally 15 minutes before sun exposure. Re-apply your BB every 1-2 hours. Wear a water resistant suncreen 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...

Label contents#

Full prescribing information#

Active ingredients:

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 9%, Octisalate 5%, Avobenzone 3%

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 balibodyco.com for further sun safety instructions.

Directions

DOSAGE & ADMINISTRATION SECTION

Shake well before use. Apply liberally 15 minutes before sun exposure. Re-apply your BB every 1-2 hours. Wear a water resistant suncreen 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Vitis Vinifera Seed Oil, Cocos Nucifera Oil, Prunus Amygdalus Dulcis Oil, Cocoglycerides, Dicaprylyl Carbonate, VP/Hexadecene Copolymer, Ethylcellulose, Sorbitan Sesquioleate, Parfum, Tocopherol, Glycerin, Ananas Sativus Fruit, Aqua, Glycine Soja Oil, Citric Acid, Sodium Benzoate, Potassium Sorbate.

Other information

OTHER SAFETY INFORMATION

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

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
70630-0037-1Bali Body Pineapple Tanning Oil SPF15100 mL in 1 BOTTLEOIL1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70630-0037BALI BODY PINEAPPLE TANNING OIL SPF15 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) OIL [BALI BODY PTY LTD]2Current NDC, 1 package rows20241023_21c49bbf-97b1-c8c0-e063-6394a90ab412.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70630-003770630-0037-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
ETHYLCELLULOSE, UNSPECIFIED7Z8S9VYZ4BIACT
GLYCERINPDC6A3C0OXIACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GRAPE SEED OIL930MLC8XGGIACT
ALMOND OIL66YXD4DKO9IACT
COCONUT OILQ9L0O73W7LIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
PINEAPPLE2A88ZO081OIACT
SOYBEAN OIL241ATL177AIACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
COCO-GLYCERIDESISE9I7DNUGIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT

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 Pineapple Tanning Oil SPF15OCTOCRYLENE, OCTISALATE, AVOBENZONEBali Body Pty Ltd21c49bbf-97b1-c8c0-e063-6394a90ab4122024-10-21WarningsExact identifier
ndc (package): 70630-0037-1
ndc (product): 70630-0037
ndc11 (package): 70630003701
spl id: 2501e696-2a31-b2c0-e063-6394a90aebe6
spl set id: 21c49bbf-97b1-c8c0-e063-6394a90ab412

Reported adverse events (FAERS/openFDA)#

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