SURFERS BARRIER- zinc oxide 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%

Purpose

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. lf 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 - 1oz Tube Label

avasol®

mineral sunscreen

30 SPF

Surf & Sport Barrier Water-resistant (80 min.)

Broad Spectrum (UVA/UVB) People-safe

Net Wt 1oz (28 g)

Principal Display Panel - 1oz Tube Label
SURFERS BARRIER 
zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58518-020
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
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)  
TOCOPHEROL (UNII: R0ZB2556P8)  
FERROUS OXIDE (UNII: G7036X8B5H)  
VANILLA BEAN (UNII: Q74T35078H)  
PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
MICA (UNII: V8A1AW0880)  
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)  
MANUKA OIL (UNII: M6QU9ZUH2X)  
ROSEMARY (UNII: IJ67X351P9)  
CINNAMON BARK OIL (UNII: XE54U569EC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58518-020-0328 g in 1 TUBE; Type 0: Not a Combination Product07/18/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/18/2013
Labeler - Avasol LLC (078822898)
Establishment
NameAddressID/FEIBusiness Operations
Avasol LLC078822898MANUFACTURE(58518-020)

Revised: 4/2023
Document Id: a7732aa0-cfd7-42a1-bfe3-e13fd2d723ba
Set id: d6e2ac0a-3bf6-4d08-8647-6a23de2ac857
Version: 4
Effective Time: 20230418
 
Avasol LLC