PRO FORMULA- zinc oxide, titanium dioxide stick 
Avasol LLC

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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Drug Facts

Active Ingredients

Zinc Oxide (non-nano, Uncoated) 24.5%

Titanium Dioxide (non-nano, Uncoated) 6%

Purpose

Sunscreen

Sunscreen

Uses

Warnings

Stop use and ask a doctor if rash or irritation occurs.

Do not use if allergic to ingredients, or nuts. Test small area first.

Keep out of reach of children. If swallowed, get medical help right away.

Directions

Inactive ingredients

*Caprylic/Capric Triglyceride (Coconut), *Cocos Nucifera (Coconut) Oil,*Helianthus annuus (Sunflower) Oil, **Euphorbia cerifera (Candelilla) wax, *Calophyllum Inophyllum (Tamanu)Oil,*Beeswax,**Theobroma Grandiflorum (Cupuacu) Seed Butter, Mica, Tocopherol (Vitamin E),*Aloe Vera Leaf, Iron oxides, *Propolis, *Rosmarinus Officinalis (Rosemary) Leaf Extract, **Leptospermum scoparium (Manuka) Oil,*Cinnamomum Zeylanicum(Cinnamon) Bark Oil.

*Organic **Wildcrafted

Other information

Questions?

visit www.avasol.com

Principal Display Panel - 28 g Tube Label

avasol®

mineral sunscreen
PRO 50+SPF

Net Wt 1 oz (28 g)

Pro-Grade Skin Barrier

Water-resistant (80 min.)

Broad Spectrum (UVA/UVB)

Safer for People & the Ocean

USDA Certified 100% Biobased

Principal Display Panel -  28 g Tube Label
PRO FORMULA 
zinc oxide, titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58518-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24.5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
COCONUT OIL (UNII: Q9L0O73W7L)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
TAMANU OIL (UNII: JT3LVK84A1)  
CANDELILLA WAX (UNII: WL0328HX19)  
THEOBROMA GRANDIFLORUM SEED (UNII: Q7RNT1G37V)  
MICA (UNII: V8A1AW0880)  
TOCOPHEROL (UNII: R0ZB2556P8)  
FERROUS OXIDE (UNII: G7036X8B5H)  
PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MANUKA OIL (UNII: M6QU9ZUH2X)  
ROSEMARY (UNII: IJ67X351P9)  
CINNAMON BARK OIL (UNII: XE54U569EC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58518-030-0328 g in 1 TUBE; Type 0: Not a Combination Product05/01/2023
2NDC:58518-030-04224 g in 1 POUCH; Type 0: Not a Combination Product05/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/01/2023
Labeler - Avasol LLC (078822898)
Establishment
NameAddressID/FEIBusiness Operations
Avasol LLC078822898MANUFACTURE(58518-030)

Revised: 4/2023
Document Id: b38abeca-fd41-42ec-a94e-3ec182c37f6b
Set id: 2c6eb04c-96e7-4fcf-a60e-2ffcf5fc8827
Version: 1
Effective Time: 20230424
 
Avasol LLC