surfers barrier spf 50

surfers barrier spf 50
SPL v5
SPL
SPL Set ID ec55eef0-17e6-416d-bd5e-548f2f323cea
Route
topical
Published
Effective Date 2020-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (24.5 g) titanium dioxide (6 g)
Inactive Ingredients
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 mica vanilla bean haematococcus pluvialis manuka oil rosemary cinnamon bark oil ferrous oxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-01-02

Purpose

Sunscreen Sunscreen

Description

Zinc Oxide (non-nano, Uncoated) 24.5% Titanium Dioxide (non-nano, Uncoated) 6%


Medication Information

Warnings
  • For external use only.
  • Keep out of eyes. Rinse with water to remove.
Uses
  • helps prevent sunburn
Purpose

Sunscreen

Sunscreen

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.
Other Information
  • protect package from moisture & extreme heat.
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

Description

Zinc Oxide (non-nano, Uncoated) 24.5% Titanium Dioxide (non-nano, Uncoated) 6%

Questions?

visit www.avasol.com

Section 50565-1

Keep out of reach of children. If swallowed, get medical help right away.

Section 50566-9

Stop use and ask a doctor if rash or irritation occurs.

Section 50570-1

Do not use if allergic to ingredients, or nuts. Test small area first.

Active Ingredients

Zinc Oxide (non-nano, Uncoated) 24.5%

Titanium Dioxide (non-nano, Uncoated) 6%

Principal Display Panel – Tube Label

avasol ®

mineral sunscreen

50+ SPF

Net Wt 1 oz (28 g)


Structured Label Content

Warnings
  • For external use only.
  • Keep out of eyes. Rinse with water to remove.
Uses
  • helps prevent sunburn
Purpose

Sunscreen

Sunscreen

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.
Other Information (Other information)
  • protect package from moisture & extreme heat.
Inactive Ingredients (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

Questions?

visit www.avasol.com

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash or irritation occurs.

Section 50570-1 (50570-1)

Do not use if allergic to ingredients, or nuts. Test small area first.

Active Ingredients

Zinc Oxide (non-nano, Uncoated) 24.5%

Titanium Dioxide (non-nano, Uncoated) 6%

Principal Display Panel – Tube Label

avasol ®

mineral sunscreen

50+ SPF

Net Wt 1 oz (28 g)


Advanced Ingredient Data


Raw Label Data

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