SURFERS BARRIER- zinc oxide stick

Surfers Barrier by

Drug Labeling and Warnings

Surfers Barrier by is a Otc medication manufactured, distributed, or labeled by Avasol LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Zinc Oxide (non-nano, Uncoated) 24.5%

Purpose

Sunscreen

Uses

• helps prevent sunburn

Warnings

• For external use only.
• Keep out of eyes. Rinse with water to remove.

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

• apply liberally before sun
• reapply: after 80 min. of swimming or sweating, immediately after towel drying, or as needed
• children under 6 months: Ask a doctor.

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), lron oxides, *Fragrance, Propolis, Plankton Extract, Mica, **Leptospermum scoparium (Manuka) Oil, *Rosmarinus Officinalis (Rosemary) Leaf Extract, *Cinnamomum Zeylanicum (Cinnamon) Bark Oil, Love. *Organic **Wildcrafted

Other information

• protect package from moisture & extreme heat

Questions?

Call 888-805-1507 or 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

• Ocean-safe Authentic
• 100% Bio-based

Net Wt 1oz (28 g)

INGREDIENTS AND APPEARANCE

SURFERS BARRIER 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58518-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	24.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
MANUKA OIL (UNII: M6QU9ZUH2X)
ROSEMARY (UNII: IJ67X351P9)
CINNAMON BARK OIL (UNII: XE54U569EC)
FERROUS OXIDE (UNII: G7036X8B5H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58518-020-03	28 g in 1 TUBE; Type 0: Not a Combination Product	07/18/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/18/2013

Labeler - Avasol LLC (078822898)

Establishment
Name	Address	ID/FEI	Business Operations
Avasol LLC		078822898	LABEL(58518-020) , PACK(58518-020) , MANUFACTURE(58518-020)