BIOSOLIS SUN SPF50- titanium dioxide 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 Sun Spray SPF50

Drug Facts

Active ingredients

Titanium Dioxide 15.9%

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

  • shake  well before each use

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 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

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

Inactive ingredients

DICAPRYLYL CARBONATE, BRASSICA CAMPESTRIS (RAPESEED) OIL *, POLYHYDROXYSTEARIC ACID, CAPRYLIC/CAPRIC TRIGLYCERIDE,
PONGAMIA GLABRA SEED OIL, DIETHYL SEBACATE, STEARIC ACID, ALUMINUM HYDROXYDE, HYDROGENATED COCONUT OIL, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, SESAMUM INDICUM SEED OIL*, COCOS NUCIFERA OIL, BISABOLOL, TOCOPHEROL, PARFUM.

Questions or comments?

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

Package Labeling:

Label

BIOSOLIS SUN SPF50 
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61296-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE159 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
KARUM SEED OIL (UNII: 62160PU6FJ)  
DIETHYL SEBACATE (UNII: I41B9FJK6V)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
SESAME OIL (UNII: QX10HYY4QV)  
LEVOMENOL (UNII: 24WE03BX2T)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61296-005-001 in 1 BOX02/01/201904/30/2024
1100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/201904/30/2024
Labeler - Pro Vera SA (375713286)

Revised: 12/2022
Document Id: eeda681d-4315-6039-e053-2a95a90aea5f
Set id: 2c2cd046-dd02-4043-9299-6ae8ba7df5ac
Version: 4
Effective Time: 20221202
 
Pro Vera SA