BIOSOLIS Extreme Fluid SPF 50

BIOSOLIS Extreme Fluid SPF 50 by

Drug Labeling and Warnings

BIOSOLIS Extreme Fluid SPF 50 by is a Otc medication manufactured, distributed, or labeled by Pro Vera SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BIOSOLIS EXTREME FLUID SPF 50- titanium dioxide, zinc oxide cream 
Pro Vera SA

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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BIOSOLIS Extreme Fluid SPF 50

Drug Facts

Active ingredients

Titanium Dioxide 10%
Zinc Oxide 15.5%

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 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 BARBADENSIS LEAF JUICE*, PONGAMIA GLABRA SEED OIL*, DIETHYL SEBACATE, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, PROPANEDIOL, STEARIC ACID, POLYGLYCERYL-3 DIISOSTEARATE, ALUMINUM HYDROXIDE, BRASSICA CAMPESTRIS OIL*, TALC, BENZYL ALCOHOL, BISABOLOL*, SODIUM CHLORIDE, DEHYDROACETIC ACID, TOCOPHEROL, PARFUM, AQUA, CITRAL, CITRONELLOL, LIMONENE, LINALOOL.

Questions or comments?

info@biosolis.info or Call

Adverse Event Reporting: 1-866-8539427

Package Labeling:

BIOSOLIS EXTREME FLUID SPF 50 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61296-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	100 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	155 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
LEVOMENOL (UNII: 24WE03BX2T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
CITRAL (UNII: T7EU0O9VPP)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
KARUM SEED OIL (UNII: 62160PU6FJ)
DIETHYL SEBACATE (UNII: I41B9FJK6V)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
PROPANEDIOL (UNII: 5965N8W85T)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626)
TALC (UNII: 7SEV7J4R1U)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61296-011-00	1 in 1 BOX	01/01/2021	12/31/2023
1		50 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	01/01/2021	12/31/2023

Labeler - Pro Vera SA (375713286)

Revised: 12/2022

Document Id: eedf75bb-90e2-513b-e053-2995a90ae261

34390-5

Set id: b78b5e63-9164-ab9f-e053-2a95a90ae863

Version: 2

Effective Time: 20221202