SURFERS BARRIER SPF 50- zinc oxide, titanium dioxide stick

SURFERS BARRIER SPF 50 by

Drug Labeling and Warnings

SURFERS BARRIER SPF 50 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%

Titanium Dioxide (non-nano. Uncoated) 6%

Purpose

Sunscreen

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. If 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), iron 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 – Tube Label

avasol®

mineral sunscreen

50+ SPF

Net Wt 1 oz (28 g)

INGREDIENTS AND APPEARANCE

SURFERS BARRIER SPF 50 
zinc oxide, titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58518-021
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6 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)
FERROUS OXIDE (UNII: G7036X8B5H)
MICA (UNII: V8A1AW0880)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
MANUKA OIL (UNII: M6QU9ZUH2X)
ROSEMARY (UNII: IJ67X351P9)
CINNAMON BARK OIL (UNII: XE54U569EC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58518-021-01	28 g in 1 TUBE; Type 0: Not a Combination Product	01/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/02/2020

Labeler - Avasol LLC (078822898)

Establishment
Name	Address	ID/FEI	Business Operations
Avasol LLC		078822898	LABEL(58518-021) , PACK(58518-021) , MANUFACTURE(58518-021)