FDA.reportPublic FDA data

BIOSOLIS Sublimating Sun Oil Spray SPF20

Manufacturer
Pro Vera SA
Effective date
2019-01-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:31:59

Label at a glance#

ProductBIOSOLIS Sublimating Sun SPF20
Active ingredientTITANIUM DIOXIDE
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 Sun 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 aBroad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 1.8%

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

  • shake  well before each use

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 if

OTC - STOP USE SECTION

  • rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact 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
  • Sun 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 aBroad 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 shirts, pants, hats and sunglasses
  • Children under 6 months of age: Ask a doctor

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

BRASSICA CAMPESTRIS SEED OIL*, PONGAMIA GLABRA SEED OIL*, DIETHYL SEBACATE, SESAMUM INDICUM SEED OIL*, PRUNUS ARMENIACA KERNEL OIL*, OLEA EUROPAEA FRUIT OIL*, DICAPRYLYL CARBONATE, HELIANTHUS ANNUUS SEED OIL*, MICA, PARFUM, STEARIC ACID, ALUMINUM HYDROXIDE, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, ALOE BARBADENSIS LEAF EXTRACT*, TOCOPHEROL, IRON OXIDE, CITRONELLOL, CITRAL, LIMONENE, LINALOOL.

Questions or comments?

OTC - QUESTIONS SECTION

info@biosolis.info or Call  Adverse Event Reporting: 1-866-8539427

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package3Outer Package3Inner Package3Inner Package3

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61296-00861296-008-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
KARUM SEED OIL62160PU6FJIACT
DIETHYL SEBACATEI41B9FJK6VIACT
SESAME OILQX10HYY4QVIACT
OLIVE OIL6UYK2W1W1EIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
SUNFLOWER OIL3W1JG795YIIACT
MICAV8A1AW0880IACT
STEARIC ACID4ELV7Z65APIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
ALOE VERA LEAFZY81Z83H0XIACT
TOCOPHEROLR0ZB2556P8IACT
FERRIC OXIDE RED1K09F3G675IACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
CITRALT7EU0O9VPPIACT
LINALOOL, (+/-)-D81QY6I88EIACT
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
b5a8599f-63d5-12ab-e053-2995a90a91bc268b6b88-e0ce-45ba-a853-c68fcffb197d2020-12-04WarningsExact identifier
spl set id: 268b6b88-e0ce-45ba-a853-c68fcffb197d

Reported adverse events (FAERS/openFDA)#

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