BIOSOLIS Sun Milk SPF 30 by Pro Vera SA BIOSOLIS Sun Milk SPF 30

BIOSOLIS Sun Milk SPF 30 by

Drug Labeling and Warnings

BIOSOLIS Sun Milk SPF 30 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 SPF 30- 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 Sun Milk SPF 30

Drug Facts

Active ingredients

Zinc Oxide 18.8%

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

ALOE BARBADENSIS LEAF JUICE*, PONGAMIA GLABRA SEED OIL*, CAPRYLIC/CAPRIC TRIGLYCERIDE, DICAPRYLYL CARBONATE, PROPANEDIOL,
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, POLYGLYCERYL-3 DIISOSTEARATE, POLYHYDROXYSTEARIC ACID, BENZYL ALCOHOL, GLYCERYL DIBEHENATE, SODIUM CHLORIDE, BISABOLOL, TRIBEHENIN, GLYCERYL BEHENATE, DEHYDROACETIC ACID, TOCOPHEROL, AQUA, PARFUM, CITRONELLOL, LIMONENE, LINALOOL.

Questions or comments?

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

Package Labeling:

BIOSOLIS SUN MILK SPF 30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61296-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	188 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
KARUM SEED OIL (UNII: 62160PU6FJ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PROPANEDIOL (UNII: 5965N8W85T)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
BENZYL ALCOHOL (UNII: LKG8494WBH)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LEVOMENOL (UNII: 24WE03BX2T)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61296-012-00	1 in 1 BOX	01/01/2021	12/31/2022
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	01/01/2021	12/31/2022

Labeler - Pro Vera SA (375713286)

Revised: 12/2022

Document Id: eedf8c4a-32dd-562a-e053-2995a90a1240

34390-5

Set id: b8691c99-eb8f-3305-e053-2995a90a9488

Version: 2

Effective Time: 20221202