Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 2c6eb04c-96e7-4fcf-a60e-2ffcf5fc8827
Route
TOPICAL
Published
Effective Date 2023-04-24
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
Medium-chain Triglycerides Coconut Oil Sunflower Oil Yellow Wax Tamanu Oil Candelilla Wax Theobroma Grandiflorum Seed Mica Tocopherol Ferrous Oxide Propolis Wax Aloe Vera Leaf Manuka Oil Rosemary Cinnamon Bark Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2023-05-01

Description

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

Purpose

Sunscreen Sunscreen


Medication Information

Purpose

Sunscreen

Sunscreen

Description

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

Uses
  • helps prevent sunburn
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.

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

visit www.avasol.com

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

Zinc Oxide (non-nano, Uncoated) 24.5%

Titanium Dioxide (non-nano, Uncoated) 6%

Inactive Ingredients

*Caprylic/Capric Triglyceride (Coconut), *Cocos Nucifera (Coconut) Oil,*Helianthus annuus (Sunflower) Oil, **Euphorbia cerifera (Candelilla) wax, *Calophyllum Inophyllum (Tamanu)Oil,*Beeswax,**Theobroma Grandiflorum (Cupuacu) Seed Butter, Mica, Tocopherol (Vitamin E),*Aloe Vera Leaf, Iron oxides, *Propolis, *Rosmarinus Officinalis (Rosemary) Leaf Extract, **Leptospermum scoparium (Manuka) Oil,*Cinnamomum Zeylanicum(Cinnamon) Bark Oil.

*Organic **Wildcrafted

Principal Display Panel 28 G Tube Label

avasol ®

mineral sunscreen

PRO 50+SPF

Net Wt 1 oz (28 g)

Pro-Grade Skin Barrier

Water-resistant (80 min.)

Broad Spectrum (UVA/UVB)

Safer for People & the Ocean

USDA Certified 100% Biobased


Structured Label Content

Uses
  • helps prevent sunburn
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.

Purpose

Sunscreen

Sunscreen

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

visit www.avasol.com

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

Zinc Oxide (non-nano, Uncoated) 24.5%

Titanium Dioxide (non-nano, Uncoated) 6%

Inactive Ingredients (Inactive ingredients)

*Caprylic/Capric Triglyceride (Coconut), *Cocos Nucifera (Coconut) Oil,*Helianthus annuus (Sunflower) Oil, **Euphorbia cerifera (Candelilla) wax, *Calophyllum Inophyllum (Tamanu)Oil,*Beeswax,**Theobroma Grandiflorum (Cupuacu) Seed Butter, Mica, Tocopherol (Vitamin E),*Aloe Vera Leaf, Iron oxides, *Propolis, *Rosmarinus Officinalis (Rosemary) Leaf Extract, **Leptospermum scoparium (Manuka) Oil,*Cinnamomum Zeylanicum(Cinnamon) Bark Oil.

*Organic **Wildcrafted

Principal Display Panel 28 G Tube Label (Principal Display Panel - 28 g Tube Label)

avasol ®

mineral sunscreen

PRO 50+SPF

Net Wt 1 oz (28 g)

Pro-Grade Skin Barrier

Water-resistant (80 min.)

Broad Spectrum (UVA/UVB)

Safer for People & the Ocean

USDA Certified 100% Biobased


Advanced Ingredient Data


Raw Label Data

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