SURFERS BARRIER SPF 50- 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

*Cocos Nucifera (Coconut) Oil, *Simmondsia Chinensis (Jojoba) Seed Oil, *Helianthus annuus (Sunflower) Oil, **Euphorbia Cerifera (Candelilla) wax *Calophyllum Inophyllum (Tamanu) Oil, *Argania spinosa (Argan) Oil, Silica, **Theobroma Grandiflorum (Cupuacu) Butter, **Mauritia Flexuosa (Buriti) Fruit Oil, *Butyrospermum Parkii (Shea Butter), Rubus idaeus (Raspberry) Seed Oil, *Beeswax, Tocopherol(Vitamin E), Iron oxides, Vanilla Planifolia (Vanilla) Fruit Extract, *Propolis, Plankton Extract, Mica, **Leptospermum scoparium (Manuka) Oil, *Rosmarinus Officinalis (Rosemary) Leaf Extract, *Cinnamomum Zeylanicum(Cinnamon) Bark Oil. **Organic **Wildcrafted

Other information

Questions?

visit www.avasol.com

Principal Display Panel – Tube Label

avasol®

mineral sunscreen

50+ SPF

Net Wt 1 oz (28 g)

Principal Display Panel – Tube Label
SURFERS BARRIER SPF 50 
zinc oxide, titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58518-021
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
COCONUT OIL (UNII: Q9L0O73W7L)  
JOJOBA OIL (UNII: 724GKU717M)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
CANDELILLA WAX (UNII: WL0328HX19)  
TAMANU OIL (UNII: JT3LVK84A1)  
ARGAN OIL (UNII: 4V59G5UW9X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
THEOBROMA GRANDIFLORUM SEED (UNII: Q7RNT1G37V)  
SHEANUT (UNII: 84H6HBP32L)  
MAURITIA FLEXUOSA WHOLE (UNII: 83ULF8L5FI)  
RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
TOCOPHEROL (UNII: R0ZB2556P8)  
MICA (UNII: V8A1AW0880)  
VANILLA BEAN (UNII: Q74T35078H)  
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)  
MANUKA OIL (UNII: M6QU9ZUH2X)  
ROSEMARY (UNII: IJ67X351P9)  
CINNAMON BARK OIL (UNII: XE54U569EC)  
FERROUS OXIDE (UNII: G7036X8B5H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58518-021-0128 g in 1 TUBE; Type 0: Not a Combination Product01/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/02/2020
Labeler - Avasol LLC (078822898)
Establishment
NameAddressID/FEIBusiness Operations
Avasol LLC078822898MANUFACTURE(58518-021)

Revised: 4/2023
Document Id: c616bbb2-56e9-4a1d-8974-2e20a4aacd98
Set id: ec55eef0-17e6-416d-bd5e-548f2f323cea
Version: 3
Effective Time: 20230411
 
Avasol LLC