FDA.reportPublic FDA data

BIOSOLIS Sunscreen Broadspectrum SPF50 KIDS

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 21:15:12

Label at a glance#

ProductBIOSOLIS Sunscreen Broadspectrum SPF50 KIDS
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
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

Titanium dioxide 10%

Zinc oxide 13.5%

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 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

ALOE VERA LEAF JUICE*, ALUMINUM HYDROXIDE,BENZYL ALCOHOL, BISABOLOL*, CAPRYLIC/CAPRICTRIGLYCERIDE, DEHYDROACETIC ACID, DICAPRYLYLCARBONATE, KARANJA TREE SEED EXTRACT,POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE,POLYGLYCERYL-3 DIISOSTEARATE,POLYHYDROXYSTEARIC ACID, PROPANEDIOL,SESAME OIL*, SODIUM CHLORIDE, STEARIC ACID,TOCOPHEROL, WATER.

Questions or comments?

OTHER SAFETY INFORMATION

1-866-853-9427

Package Labeling:61296-014-00

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF50 KIDS outer levelSPF50 KIDS outer levelSPF50 kids front tubeSPF50 kids front tube

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61296-01461296-014-00

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
ALOE VERA LEAFZY81Z83H0XIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
BENZYL ALCOHOLLKG8494WBHIACT
LEVOMENOL24WE03BX2TIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
DEHYDROACETIC ACID2KAG279R6RIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
PONGAMIA PINNATA SEEDC2BRV53B1VIACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
PROPANEDIOL5965N8W85TIACT
SESAME OILQX10HYY4QVIACT
SODIUM CHLORIDE451W47IQ8XIACT
STEARIC ACID4ELV7Z65APIACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
ZINC OXIDESOI2LOH54ZACTIM
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
0e993203-3e8d-5fbd-e063-6294a90a0636cc80a2d1-147d-4f0f-9cd4-47683034a6392024-01-10WarningsExact identifier
spl id: 0e993203-3e8d-5fbd-e063-6294a90a0636
spl set id: cc80a2d1-147d-4f0f-9cd4-47683034a639

Reported adverse events (FAERS/openFDA)#

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