BIOSOLIS MELT IN SUN SPF30- titanium dioxide cream

BIOSOLIS Melt in Sun SPF30 by

Drug Labeling and Warnings

BIOSOLIS Melt in Sun SPF30 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 7.5%

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
• 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

BRASSICA CAMPESTRIS ( SEED ) OIL*, DICAPRYLYL CARBONATE, CAPRYLIC/ CAPRIC TRIGLYCERIDE, C10-C18 TRIGLYCERIDES, SESAMUM INDICUM SEED OIL*, PONGAMIA GLABRA SEED OIL*, DIETHYL SEBACATE,  HYDROGENATED CASTOR OIL, STEARIC ACID, ALUMINUM HYDROXYDE, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, PARFUM, TOCOPHERO.

Questions or comments?

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

Package Labeling:

INGREDIENTS AND APPEARANCE

BIOSOLIS MELT IN SUN SPF30 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61296-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)
SESAME OIL (UNII: QX10HYY4QV)
KARUM SEED OIL (UNII: 62160PU6FJ)
DIETHYL SEBACATE (UNII: I41B9FJK6V)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61296-007-00	1 in 1 BOX	02/01/2019
1		100 mL in 1 BOTTLE, PUMP; 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)