FDA.reportPublic FDA data

Benefit Hello Happy Soft Blur Foundation SPF 15

Manufacturer
Benefit Cosmetics, LLC
Effective date
2019-09-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:12:39

Label at a glance#

ProductBenefit Hello Happy Soft Blur Foundation SPF 15 Shade 2
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure8 sections

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Children under 6 months of age: ask a doctor. Skin 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 meas...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

OCTINOXATE 5.00%

TITANIUM DIOXIDE 2.06%

Purpose

OTC - PURPOSE SECTION

SUNSCREEN

Use

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

  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Children under 6 months of age: ask a doctor.
  • Skin 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. till 2 p.m.
  • Wear long-sleeved shirts, pants, hats & sunglasses.

Other information

SPL UNCLASSIFIED SECTION

Protect the product in this container from excessive heat or direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water), Phenyl Trimethicone, Alcohol Denat., Dimethicone, Isododecane, Silica, Butylene Glycol, Peg-10 Dimethicone, Methyl Methacrylate Crosspolymer, Polymethylsilsesquioxane, Mica, Sodium Chloride, Dimethicone/Peg-10/15 Crosspolymer, Isohexadecane, Squalane, Potassium Sorbate, Sodium Dehydroacetate, Disodium Stearoyl Glutamate, Tocopheryl Acetate, Isopropyl Titanium Triisostearate, Aluminum Hydroxide, Dipropylene Glycol, Butyrospermum Parkii (Shea) Seedcake Extract, Sodium Citrate, Tocopherol. [+/-: CI 77163 (Bismuth Oxychloride), CI 77491, CI 77492, CI 77499 (Iron Oxides), CI 77891 (Titanium Dioxide)].

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Shade 2Shade 2

Updated Labels:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package 2Outer Package 2Inner Package 2Inner Package 2BoxBoxShade3Shade3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66472-045-012023-02-08C16284748780-1f386c64a-4593-0266-e053-dadaa90a7c1aBenefit Hello Happy Soft Blur Foundation SPF 15 - Shade 2
66472-045-032023-02-08C16284748780-1f386c64a-4593-0266-e053-dadaa90a7c1aBenefit Hello Happy Soft Blur Foundation SPF 15 - Shade 2
66472-045-012023-01-30C16284748780-1f386c64a-4593-0266-e053-dadaa90a7c1aBenefit Hello Happy Soft Blur Foundation SPF 15 - Shade 2
66472-045-032023-01-30C16284748780-1f386c64a-4593-0266-e053-dadaa90a7c1aBenefit Hello Happy Soft Blur Foundation SPF 15 - Shade 2

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66472-04566472-045-01, 66472-045-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
ALCOHOL3K9958V90MIACT
DIMETHICONE92RU3N3Y1OIACT
ISODODECANEA8289P68Y2IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
MICAV8A1AW0880IACT
SODIUM CHLORIDE451W47IQ8XIACT
ISOHEXADECANE918X1OUF1EIACT
SQUALANEGW89575KF9IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM DEHYDROACETATE8W46YN971GIACT
DISODIUM STEAROYL GLUTAMATE45ASM2L11MIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ISOPROPYL TITANIUM TRIISOSTEARATE949E3KBJ1IIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
DIPROPYLENE GLYCOLE107L85C40IACT
SODIUM CITRATE1Q73Q2JULRIACT
TOCOPHEROLR0ZB2556P8IACT
BISMUTH OXYCHLORIDE4ZR792I587IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB

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
f437624e-16d4-345a-e053-2a95a90a0eb0fe6eab9b-ca95-48bf-ab14-be2bc995191e2023-02-08WarningsExact identifier
spl set id: fe6eab9b-ca95-48bf-ab14-be2bc995191e

Reported adverse events (FAERS/openFDA)#

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