FDA.reportPublic FDA data

Brush On Block Sun Shine SPF 30 Protective Lip Oil Coral

Manufacturer
SPF Ventures LLC | Dermaceutical Laboratories Limited Liability
Effective date
2024-03-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:09:36

Label at a glance#

ProductBrush On Block Sun Shine SPF 30 Protective Lip Oil Coral
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
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

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. Sunprotection 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...

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

titanium dioxide 4.5%

zinc oxide 3.4%

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

Do not use on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor 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 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.
  • Sunprotection 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 10am-2pm
  • wear long-sleeved shirts, pants, hats and sunglasses.

Inactive ingredients

INACTIVE INGREDIENT SECTION

ALUMINA

ARGANIA SPINOSA KERNEL OIL

BISABOLOL

BUTYLENE/ETHYLENE/STYRENE COPOLYMER

BUTYLOCTYL SALICYLATE

CAPRYLIC/CAPRIC TRIGLYCERIDE

CAPRYLYL GLYCOL

CITRUS RETICULATA (TANGERINE) PEEL OIL

ETHYLENE/PROPYLENE/STYRENE COPOLYMER

FLAVOR

HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL

HYDROGENATED POLYISOBUTENE

IRON OXIDES

PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE

POLYHYDROXYSTEARIC ACID

RICINUS COMMUNIS (CASTOR) SEED OIL

STEARIC ACID

TOCOPHERYL ACETATE

Other information

STORAGE AND HANDLING SECTION

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

label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58274-017-01Brush On Block Sun Shine SPF 30 Protective Lip Oil Coral6.8 mL in 1 TUBEOIL6.81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58274-017BRUSH ON BLOCK SUN SHINE SPF 30 PROTECTIVE LIP OIL CORAL (TITANIUM DIOXIDE/ZINC OXIDE) OIL [SPF VENTURES LLC]1Current NDC, 1 package rows20240310_12e65634-2e6d-b030-e063-6294a90ad1c4.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
58274-01758274-017-01

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
CASTOR OILD5340Y2I9GIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
ARGAN OIL4V59G5UW9XIACT
CAPRYLYL GLYCOL00YIU5438UIACT
FERRIC OXIDE RED1K09F3G675IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ALUMINUM OXIDELMI26O6933IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
STEARIC ACID4ELV7Z65APIACT
ZINC OXIDESOI2LOH54ZACTIB
MANDARIN OILNJO720F72RIACT
LEVOMENOL24WE03BX2TIACT
SUNFLOWER OIL3W1JG795YIIACT
HYDROGENATED POLYBUTENE (1300 MW)7D1YQ9Y5EZIACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ETHYLHEXYL PALMITATE2865993309IACT

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
Brush On Block Sun Shine SPF 30 Protective Lip Oil CoralTITANIUM DIOXIDE/ZINC OXIDESPF Ventures LLC12e65634-2e6d-b030-e063-6294a90ad1c42024-03-05WarningsExact identifier
ndc (package): 58274-017-01
ndc (product): 58274-017
ndc11 (package): 58274001701
spl id: 12e64c55-e6bb-a4c8-e063-6294a90a13e9
spl set id: 12e65634-2e6d-b030-e063-6294a90ad1c4

Reported adverse events (FAERS/openFDA)#

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