BIOSOLIS SUN MILK UVA SUNSCREEN FACE AND BODY BROAD SPECTRUM SPF15- titanium dioxide, zinc oxide cream

BIOSOLIS Sun Milk UVA Sunscreen Face and Body Broad Spectrum SPF15 by

Drug Labeling and Warnings

BIOSOLIS Sun Milk UVA Sunscreen Face and Body Broad Spectrum SPF15 by is a Otc medication manufactured, distributed, or labeled by Pro Vera SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BIOSOLIS Sun Milk UVA Sunscreen Face and Body Broad Spectrum SPF15

Active ingredients

Titanium Dioxide 6.34%
Zinc Oxide 4.85%

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

*Ingredient from Organic Farming  99% of the total ingredients are from natural origin 51.70% of the total ingredients are from organic farming.

Questions or comments?

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

BIOSOLIS Sun Milk UVA Sunscreen Face and Body Broad Spectrum SPF15 3.4oz/100ml (

61296-000-00)

INGREDIENTS AND APPEARANCE

BIOSOLIS SUN MILK UVA SUNSCREEN FACE AND BODY BROAD SPECTRUM SPF15 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61296-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	63.4 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	48.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
COCONUT ALKANES (UNII: 1E5KJY107T)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
PROPANEDIOL (UNII: 5965N8W85T)
KARUM SEED OIL (UNII: 62160PU6FJ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626)
CARROT (UNII: L56Z1JK48B)
SUNFLOWER OIL (UNII: 3W1JG795YI)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM OXIDE (UNII: LMI26O6933)
LACTIC ACID (UNII: 33X04XA5AT)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61296-000-00	100 mL in 1 TUBE; 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(61296-000)