BIOSOLIS EXTREME FLUID UVA SUNSCREEN BROAD SPECTRUM FACE AND NECK SPF50- titanium dioxide, zinc oxide cream

BIOSOLIS Extreme Fluid UVA Sunscreen Broad Spectrum Face and Neck SPF50 by

Drug Labeling and Warnings

BIOSOLIS Extreme Fluid UVA Sunscreen Broad Spectrum Face and Neck SPF50 by is a Otc medication manufactured, distributed, or labeled by Pro Vera SA, Le Conditionnement Belge. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BIOSOLIS Extreme Fluid UVA Sunscreen Broad Spectrum Face and Neck SPF50

Active ingredients

Titanium Dioxide 16.80%
Zinc Oxide 9.70%

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
• Uses 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 (ALOE BARBADENSIS) GEL*, COCONUT ALKANES, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, PROPANEDIOL, KARANJA (PONGAMIA GLABRA) SEED OIL*, POLYGLYCERYL-3 DIISOSTEARATE, POLYHYDROXYSTEARIC ACID, STEARIC ACID, ALUMINUM HYDROXIDE, SODIUM CHLORIDE, RAPESEED (BRASSICA CAMPESTRIS) OIL*, CARROT (DAUCUS CAROTA SATIVA) ROOT EXTRACT*, SUNFLOWER (HELIANTHUS ANNUUS) SEED OIL*, COCO-CAPRYLATE/CAPRATE, ALUMINA, POTASSIUM SORBATE, SODIUM BENZOATE, FRAGRANCE, LACTIC ACID, TOCOPHEROL.

*Ingredient from Organic Farming  99% of the total ingredients are from natural origin 25.70% of the total ingredients are from organic farming.

Questions or comments?

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

BIOSOLIS Extreme Fluid UVA Sunscreen Broad Spectrum Face and Neck SPF50 1.35oz/40ml (

61296-003-00)

INGREDIENTS AND APPEARANCE

BIOSOLIS EXTREME FLUID UVA SUNSCREEN BROAD SPECTRUM FACE AND NECK SPF50 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61296-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	168 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	97 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
COCONUT ALKANES (UNII: 1E5KJY107T)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
PROPANEDIOL (UNII: 5965N8W85T)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCO-CAPRYLATE (UNII: 4828G836N6)
ALUMINUM OXIDE (UNII: LMI26O6933)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
LACTIC ACID (UNII: 33X04XA5AT)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61296-003-00	40 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/02/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/02/2013

Labeler - Pro Vera SA (375713286)

Establishment
Name	Address	ID/FEI	Business Operations
Pro Vera SA		375713286	manufacture(61296-003)