FDA.reportPublic FDA data

BIOSOLIS Sunscreen spray broadspectrum SPF30

Manufacturer
Pro Vera SA
Effective date
2024-01-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:15:04

Label at a glance#

ProductBIOSOLIS Sunscreen broadspectrum SPF30
Active ingredientZINC OXIDE
Label structure9 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 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. – 3 p.m. wear long-sleeved shirts, pants, hats and sunglasses reapply after...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 18.8%

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

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
  • 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. – 3 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
  • reapply
  • after 40 minutes swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • children under 6 months of age: Ask a doctor

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

BISABOLOL*, CAPRYLIC/CAPRIC TRIGLYCERIDE,COCONUT OIL*, DICAPRYLYL CARBONATE,FRAGANCE, HYDROGENATED COCONUT OIL**,KARANJA TREE SEED EXTRACT, LIMONENE,LINALOOL, POLYHYDROXYSTEARIC ACID,SESAME OIL*, TOCOPHEROL.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-853-9427

Package Labeling:61296-015-00

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF30 spray outer levelSPF30 spray outer levelSPF30 spray bottleSPF30 spray bottle

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61296-01561296-015-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
LEVOMENOL24WE03BX2TIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
COCONUT OILQ9L0O73W7LIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
HYDROGENATED COCONUT OILJY81OXM1OMIACT
PONGAMIA PINNATA SEEDC2BRV53B1VIACT
LIMONENE, (+)-GFD7C86Q1WIACT
LINALOOL, (+/-)-D81QY6I88EIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
SESAME OILQX10HYY4QVIACT
TOCOPHEROLR0ZB2556P8IACT
ZINC OXIDESOI2LOH54ZACTIM

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
0e9956da-6dae-1d02-e063-6294a90a87960f096095-242f-47c6-8a8b-e52fca711c0d2024-01-10WarningsExact identifier
spl id: 0e9956da-6dae-1d02-e063-6294a90a8796
spl set id: 0f096095-242f-47c6-8a8b-e52fca711c0d

Reported adverse events (FAERS/openFDA)#

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