FDA.reportPublic FDA data

BB Cream SPF 20 Fair

Manufacturer
J. A. Cosmetics U.S. INC | Columbia Cosmetics Manufacturing, Inc.
Effective date
2020-12-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:35:42

Label at a glance#

ProductBB Cream SPF 20 Fair
Active ingredientOCTINOXATE, OXYBENZONE, OCTISALATE
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 aging caused by the sun

Dosage and administration

For sunscreen use: apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating Sun Protection Measures: Spending time in the sun increases your risk of sun 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 th...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 6.0%

Octisalate 4.0%

Oxybenzone 3.5%

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 aging 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures: Spending time in the sun increases your risk of sun 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 shirt, pants, hats and sunglasses
    • children under 6 months of age: Ask doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerin, Propylene Glycol, C12-15 Alkyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Cyclopentasiloxane, Cyclohexasiloxane, Sorbitan Olivate, Polymethyl Methacrylate, Sodium Chloride, Quatemium-18 Bentonite, Quartz, Triethoxycaprylylsilane, Zinc Stearate, Talc, Vp/Hexadecene Copolymer, Bisabolol, Tocopheryl Acetate (Ve), Simmondsia Chinensis (Jojoba) Seed Oil, Aloe Barbadensis Leat Extract, Cucumis Sativus (Cucumber) Fruit Extract, Mica, Silica, Butylene Glycol, Phenoxyethanol, Ethylhexylglycerin, Caprylyl Glycol, Fragrance (Parfum) May Contain: Iron Oxides (Cl 77491, Cl 77492, Cl 77499), Titanium Dioxide (Cl 77891)

Questions or comments?

OTC - QUESTIONS SECTION

1-855-353-7320

Principal Display Panel - 28.5 mL Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

e.l.f.

BB CREAM

SPF 20

sunscreen

fair

NET 0.96 FL. OZ. (28.5mL)

Principal Display Panel - 28.5 mL Carton LabelPrincipal Display Panel - 28.5 mL Carton Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76354-861-012023-01-30C16284748780-1f386c649-c06e-0266-e053-dadaa90a7c1aBB Cream SPF 20 Fair

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76354-861-01BB Cream SPF 20 Fair28.5 mL in 1 BOTTLECREAM28.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76354-861BB CREAM SPF 20 FAIR (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [J. A. COSMETICS U.S. INC]1Legacy NDC, 1 package rows20201223_b7059009-a0d2-6fc2-e053-2a95a90ae1a2.zip

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
76354-86176354-861-01

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
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
WATER059QF0KO0RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MICAV8A1AW0880IACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
SORBITAN OLIVATEMDL271E3GRIACT
SODIUM CHLORIDE451W47IQ8XIACT
BENTOQUATAM7F465U79Q1IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ZINC STEARATEH92E6QA4FVIACT
TALC7SEV7J4R1UIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
JOJOBA OIL724GKU717MIACT
CUCUMBERYY7C30VXJTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CYCLOMETHICONE 50THT5PCI0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CYCLOMETHICONE 6XHK3U310BAIACT
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
OCTISALATE4X49Y0596WACTIB
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
LEVOMENOL24WE03BX2TIACT

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
b6aff558-c521-4978-e053-2995a90a311db7059009-a0d2-6fc2-e053-2a95a90ae1a22020-12-17WarningsExact identifier
spl id: b6aff558-c521-4978-e053-2995a90a311d
spl set id: b7059009-a0d2-6fc2-e053-2a95a90ae1a2

Reported adverse events (FAERS/openFDA)#

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