FDA.reportPublic FDA data

Tan BB Cream SPF15

Manufacturer
Bali Body Pty Ltd
Effective date
2020-12-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:58:08

Label at a glance#

ProductTan BB Cream SPF15
Active ingredientOCTOCRYLENE, OCTINOXATE, AVOBENZONE, OXYBENZONE
Label structure6 sections

Dosage and administration

Apply to clean skin with fingertips. Layer for additional coverage.

Label contents#

Full prescribing information#

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply to clean skin with fingertips. Layer for additional coverage.

Warnings:

WARNINGS SECTION

For external use only. Keep out of direct sunlight or other sources of strong light. Product to be stored beteen 5-28°C. Discontinues use if irritation occurs. Subtle variations in appearance and texture of this product in no way affect its integrity.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Please refer to balibodyco.com for further sun-safety instructions.

Use:

INDICATIONS & USAGE SECTION

Helps prevent sunburn, If used with other sun protection measures decreases the risk of skin cancer.

Active ingredients:

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 6%
Octinoxate 4.9%
Avobenzone 3%
Oxybenzone 3%

Purpose:

OTC - PURPOSE SECTION

Sunsreen

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Water (Aqua), Propylene Glycol, Ethylhexyl Stearate, Cyclopentasiloxane, Glyceryl Stearate, Vitis Vinifera (Grape) Seed Oil, Tapioca Starch, Cyclohexasiloxane, Cetearyl Alcohol, Potassium Cetyl Phosphate, Cetearyl Olivate, Glycerin, Sodium Hyaluronate, Camellia Sinensis Leaf Extract, Acanthopanax Senticosus (Eleuthero) Root Extract, Hydrolyzed Collagen, Sorbitan Olivate, Phytic Acid, Butylene Glycol, BHT, Fragrance (Parfum), Sodium Hydroxide, Phenoxyethanol, Benzyl Alcohol, Ethyylhexylglycerin, Potassium Sorbate, Mica, Iron Oxides CI 77492, CI 77491, CI 77499, Titanium Dioxide (CI77891)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle13Bottle13

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70630-001370630-0013-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
CYCLOMETHICONE 50THT5PCI0RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
GRAPE SEED OIL930MLC8XGGIACT
STARCH, TAPIOCA24SC3U704IIACT
CYCLOMETHICONE 6XHK3U310BAIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
CETEARYL OLIVATE58B69Q84JOIACT
GLYCERINPDC6A3C0OXIACT
HYALURONATE SODIUMYSE9PPT4THIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ELEUTHEROZQH6VH092ZIACT
SORBITAN OLIVATEMDL271E3GRIACT
FYTIC ACID7IGF0S7R8IIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
SODIUM HYDROXIDE55X04QC32IIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BENZYL ALCOHOLLKG8494WBHIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
MICAV8A1AW0880IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
OCTOCRYLENE5A68WGF6WMACTIB
OCTINOXATE4Y5P7MUD51ACTIB
AVOBENZONEG63QQF2NOXACTIB
OXYBENZONE95OOS7VE0YACTIB

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
d28f1e77-cc97-c3da-e053-2995a90a9b5105d1ced9-99d0-4765-bd9f-5c8db5c2a1f62021-12-07WarningsExact identifier
spl set id: 05d1ced9-99d0-4765-bd9f-5c8db5c2a1f6

Reported adverse events (FAERS/openFDA)#

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