SPL v1
SPL
SPL Set ID 25a7510f-5ef3-9920-e063-6394a90a2079
Route
TOPICAL
Published
Effective Date 2022-08-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (35 mg)
Inactive Ingredients
Yellow Wax Lavandula Angustifolia Flower Olive Oil Tocopherol Plantago Major Leaf Achillea Millefolium Flower Spearmint Oil Calendula Officinalis Flower Comfrey Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-02

Description

UVA/UVB BROAD SPECTRUM SPF 15 Spearmint Sunscreen Lip Balm Coconut Sunscreen Lip Balm

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

UVA/UVB BROAD SPECTRUM SPF 15 Spearmint Sunscreen Lip Balm Coconut Sunscreen Lip Balm

Uses
  • Helps prevent sunburn
Section 42229-5

UVA/UVB BROAD SPECTRUM SPF 15

Spearmint Sunscreen Lip Balm

Coconut Sunscreen Lip Balm

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9
  • Stop use and ask a doctor if rash occurs
Section 50567-7
  • When using this product keep out of eyes. Rinse with water to remove.
Section 50570-1
  • Do not use on damaged or broken skin
Section 51945-4

NAPLES SOAP COMPANY

SPF 15

Spearmint Lip Balm

NET WT 0.15 OZ (4.2 g)

Warnings

For external use only

Directions
  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Children under 6 months of age: Ask a doctor

Sun Protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
Active Ingredient

Zinc Oxide 3.5%

Other Information
  • Protect this product from excessive heat and direct sun
Inactive Ingredients

Organic Calendula, Organic Comfrey, Organic Lavender, Organic Plantain and Organic Yarrow Infused in Organic Extra Virgin Olive Oil with Organic Beeswax, Organic Coconut Flavor and Non-GMO Vitamin E.


Structured Label Content

Uses
  • Helps prevent sunburn
Section 42229-5 (42229-5)

UVA/UVB BROAD SPECTRUM SPF 15

Spearmint Sunscreen Lip Balm

Coconut Sunscreen Lip Balm

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)
  • Stop use and ask a doctor if rash occurs
Section 50567-7 (50567-7)
  • When using this product keep out of eyes. Rinse with water to remove.
Section 50570-1 (50570-1)
  • Do not use on damaged or broken skin
Section 51945-4 (51945-4)

NAPLES SOAP COMPANY

SPF 15

Spearmint Lip Balm

NET WT 0.15 OZ (4.2 g)

Purpose

Sunscreen

Warnings

For external use only

Directions
  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Children under 6 months of age: Ask a doctor

Sun Protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
Active Ingredient (Active ingredient)

Zinc Oxide 3.5%

Other Information (Other information)
  • Protect this product from excessive heat and direct sun
Inactive Ingredients (Inactive ingredients)

Organic Calendula, Organic Comfrey, Organic Lavender, Organic Plantain and Organic Yarrow Infused in Organic Extra Virgin Olive Oil with Organic Beeswax, Organic Coconut Flavor and Non-GMO Vitamin E.


Advanced Ingredient Data


Raw Label Data

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