BIOSOLIS EXTREME FLUID SPF 50- titanium dioxide, zinc oxide cream 
Pro Vera SA

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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BIOSOLIS Extreme Fluid SPF 50

Drug Facts

Active ingredients

Titanium Dioxide 10%
Zinc Oxide 15.5%

Purpose

Sunscreen

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.

Warnings

For external use only

Do not use

  • on damaged or broken skin

When using this product

  • keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if

  • rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away

Directions

  • 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 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. – 2 p.m.
  • Wear long-sleeved shirts, pants, hats and sunglasses
  • Children under 6 months of age: Ask a doctor

Other information

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

Inactive ingredients

DICAPRYLYL CARBONATE, ALOE BARBADENSIS LEAF JUICE*, PONGAMIA GLABRA SEED OIL*, DIETHYL SEBACATE, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, PROPANEDIOL, STEARIC ACID, POLYGLYCERYL-3 DIISOSTEARATE, ALUMINUM HYDROXIDE, BRASSICA CAMPESTRIS OIL*, TALC, BENZYL ALCOHOL, BISABOLOL*, SODIUM CHLORIDE, DEHYDROACETIC ACID, TOCOPHEROL, PARFUM, AQUA, CITRAL, CITRONELLOL, LIMONENE, LINALOOL.

Questions or comments?

info@biosolis.info or Call

Adverse Event Reporting: 1-866-8539427

Package Labeling:

Outer Label2Inner Label2

BIOSOLIS EXTREME FLUID SPF 50 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61296-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE100 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION155 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
LEVOMENOL (UNII: 24WE03BX2T)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
TOCOPHEROL (UNII: R0ZB2556P8)  
WATER (UNII: 059QF0KO0R)  
CITRAL (UNII: T7EU0O9VPP)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
KARUM SEED OIL (UNII: 62160PU6FJ)  
DIETHYL SEBACATE (UNII: I41B9FJK6V)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
PROPANEDIOL (UNII: 5965N8W85T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626)  
TALC (UNII: 7SEV7J4R1U)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61296-011-001 in 1 BOX01/01/202112/31/2023
150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/202112/31/2023
Labeler - Pro Vera SA (375713286)

Revised: 12/2022
Document Id: eedf75bb-90e2-513b-e053-2995a90ae261
Set id: b78b5e63-9164-ab9f-e053-2a95a90ae863
Version: 2
Effective Time: 20221202
 
Pro Vera SA