BIOSOLIS FACE UVA SUNSCREEN BROAD SPECTRUM SPF30- titanium dioxide, zinc oxide cream

BIOSOLIS Face UVA Sunscreen Broad Spectrum SPF30 by

Drug Labeling and Warnings

BIOSOLIS Face UVA Sunscreen Broad Spectrum SPF30 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 Face Cream UVA Sunscreen Broad Spectrum SPF30

Active ingredients

Titanium Dioxide 9%
Zinc Oxide 6.79%

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

ALOE (ALOE BARBADENSIS) GEL*, DICAPRYLYL CARBONATE, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, KARANJA (PONGAMIA GLABRA) SEED OIL*, POLYGLYCERYL-3 DIISOSTEARATE, BEESWAX, STEARIC ACID, ALUMINUM HYDROXIDE, PROPANEDIOL, SODIUM CHLORIDE, RAPESEED (BRASSICA CAMPESTRIS) OIL*, CARROT (DAUCUS CAROTA SATIVA) ROOT EXTRACT*, SUNFLOWER (HELIANTHUS ANNUUS) SEED OIL*, POTASSIUM SORBATE, SODIUM BENZOATE, FRAGRANCE, LACTIC ACID, TOCOPHEROL.

*Ingredient from Organic Farming  99% of the total ingredients are from natural origin 43.70% of the total ingredients are from organic farming.

Questions or comments?

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

BIOSOLIS Face Cream UVA Sunscreen Broad Spectrum SPF30 1.7/50ml (

61296-004-00)

INGREDIENTS AND APPEARANCE

BIOSOLIS FACE UVA SUNSCREEN BROAD SPECTRUM SPF30 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61296-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	90 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	67.9 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
YELLOW WAX (UNII: 2ZA36H0S2V)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
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: 61296-004-00	50 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(61296-004)