OTC Medication Information: SURFERS BARRIER SPF 50

SURFERS BARRIER SPF 50- zinc oxide and 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.

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)

Principal Display Panel – Tube Label
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 24.5 g in 100 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 6 g in 100 g
Inactive Ingredients
Ingredient Name Strength
COCONUT OIL
JOJOBA OIL
SUNFLOWER OIL
CANDELILLA WAX
TAMANU OIL
ARGAN OIL
SILICON DIOXIDE
THEOBROMA GRANDIFLORUM SEED
SHEANUT
MAURITIA FLEXUOSA WHOLE
RUBUS IDAEUS SEED
YELLOW WAX
PROPOLIS WAX
TOCOPHEROL
FERROUS OXIDE
MICA
HAEMATOCOCCUS PLUVIALIS
MANUKA OIL
ROSEMARY
CINNAMON BARK OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58518-021-01 28 g in 1 TUBE None
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 Operations
Avasol LLC 078822898 LABEL (58518-021), PACK (58518-021), MANUFACTURE (58518-021)

Revised: 01/2020 Avasol LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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