BIOSOLIS SUNSCREEN BROADSPECTRUM SPF30- 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.

----------

BIOSOLIS Sunscreen spray broadspectrum SPF30

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
  • 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. – 3 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
  • reapply
  • after 40 minutes swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • 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

BISABOLOL*, CAPRYLIC/CAPRIC TRIGLYCERIDE,COCONUT OIL*, DICAPRYLYL CARBONATE,FRAGANCE, HYDROGENATED COCONUT OIL**,KARANJA TREE SEED EXTRACT, LIMONENE,LINALOOL, POLYHYDROXYSTEARIC ACID,SESAME OIL*, TOCOPHEROL.

Questions or comments?

1-866-853-9427

Package Labeling:61296-015-00

SPF30 spray outer levelSPF30 spray bottle

BIOSOLIS SUNSCREEN BROADSPECTRUM SPF30 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61296-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION188 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
LEVOMENOL (UNII: 24WE03BX2T)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
COCONUT OIL (UNII: Q9L0O73W7L)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SESAME OIL (UNII: QX10HYY4QV)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61296-015-001 in 1 BOX01/07/2022
1100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/07/2022
Labeler - Pro Vera SA (375713286)
Registrant - Pro Vera SA (375713286)

Revised: 8/2022
Document Id: e6eaef45-950c-632e-e053-2995a90ad5cc
Set id: 0f096095-242f-47c6-8a8b-e52fca711c0d
Version: 1
Effective Time: 20220823
 
Pro Vera SA