FDA.reportPublic FDA data

BB Cream SPF20

Manufacturer
e.l.f. Cosmetics, Inc
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:42:45

Label at a glance#

ProductBB SPF20
Active ingredientOCTINOXATE, OCTISALATE, OXYBENZONE
Label structure7 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  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: Sun Protection Measures:  limit time in ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 6%

Octisalate 4%

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 
  • 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: Sun Protection Measures: 
  • limit time in the sun, especially from 10 a.m.-2 p.m
  • wear long-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: Ask doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-855-353-7320

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76354-450-28BB SPF201 in 1 BOXCREAM17
76354-450-28BB SPF2028.5 mL in 1 BOTTLECREAM28.57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76354-450BB SPF20 (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [E.L.F. COSMETICS, INC]7Legacy NDC, 2 package rows20241215_25b6dc60-7480-42cf-acd3-4155d6e57b1f.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76354-45076354-450-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
CYCLOMETHICONE 50THT5PCI0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CYCLOMETHICONE 6XHK3U310BAIACT
SORBITAN OLIVATEMDL271E3GRIACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
SODIUM CHLORIDE451W47IQ8XIACT
TALC7SEV7J4R1UIACT
JOJOBA OIL724GKU717MIACT
CUCUMBERYY7C30VXJTIACT
ALOE VERA LEAFZY81Z83H0XIACT
LEVOMENOL24WE03BX2TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
BENTOQUATAM7F465U79Q1IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ZINC STEARATEH92E6QA4FVIACT
ZINC PALMITATEQ7407964JAIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MICAV8A1AW0880IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CAPRYLYL GLYCOL00YIU5438UIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
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
2918e52c-410a-3610-e063-6294a90aafe025b6dc60-7480-42cf-acd3-4155d6e57b1f2024-12-12WarningsExact identifier
spl id: 2918e52c-410a-3610-e063-6294a90aafe0
spl set id: 25b6dc60-7480-42cf-acd3-4155d6e57b1f

Reported adverse events (FAERS/openFDA)#

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