BIOSOLIS SUN SPF50- titanium dioxide cream

BIOSOLIS Sun SPF50 by

Drug Labeling and Warnings

BIOSOLIS Sun SPF50 by is a Otc medication manufactured, distributed, or labeled by Pro Vera SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

BIOSOLIS SUN SPF50 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61296-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	159 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61296-005-00	1 in 1 BOX	02/01/2019
1		100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2019

Labeler - Pro Vera SA (375713286)