101s Naples Soap Co Peppermint Spf 15 Broad Spectrum Sunscreen Lip Balm

101s Naples Soap Co Peppermint Spf 15 Broad Spectrum Sunscreen Lip Balm
SPL v3
SPL
SPL Set ID 24adffd4-5177-f5d5-e063-6294a90a7850
Route
TOPICAL
Published
Effective Date 2024-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 g) Avobenzone (3 g) Octocrylene (5 g) Octisalate
Inactive Ingredients
Peppermint Rosemary Cocoa Butter Aloe Vera Leaf Tocopherol Calendula Officinalis Flower Sunflower Oil Yellow Wax Coconut Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-27

Description

Active ingredients Avobenzone 3%, Octinoxate 7.5%, Octisalate 5%, Octocrylene 5%


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Use helps prevent sunburn

Dosage and Administration

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistance sunscreen if swimming or sweating
  • 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
  • children under 6 months of age: ask a doctor
Description

Active ingredients Avobenzone 3%, Octinoxate 7.5%, Octisalate 5%, Octocrylene 5%

Section 42229-5

NAPLES

SOAP COMPANY

SUNSCREEN

Broad spectrum SPF 15

-15-

Lip Balm

.15 oz / 4.25 g

Peppermint

Distributed by: Naples Soap Company

Fort Myers, FL 33913

naplessoap.com - (239) 325-8263

Made in USA from

foreign & domestic parts - 84489

Section 44425-7

Other information protect this product from excessive heat and direct sun

Section 50565-1

Keep out of reach of children

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product, keep out of eyes

Section 50570-1

Do not use on damaged or broken skin

Section 51727-6

Inactive ingredients

Helianthus Annuus (Sunflower) Seed Oil*, Cera Flava (Beeswax)*, Theobroma Cacao (Cocoa) Seed Butter*, Cocos Nucifera (Coconut) Oil*, Essential Oil of Mentha Piperita (Peppermint) Leaf Oil*, Aloe Barbadensis (Aloe Vera) Leaf Oil*, Mixed Tocopherols (Vitamin E), Rosmarinus Officinalis (Rosemary) Leaf Extract*, Calendula Officinalis (Calendula) Flower Extract*. *Organic Ingredient

Section 51945-4

Net Wt. 0.15 oz (4.25 g)

Section 53413-1

Questions or comments?

Questions? 1-888-256-8265 or visit www.naplessoap.com

Section 55105-1

Purpose:

Sunscreen

Section 55106-9

Active ingredients

Avobenzone 3%, Octinoxate 7.5%, Octisalate 5%, Octocrylene 5%


Structured Label Content

Indications and Usage (34067-9)

Use helps prevent sunburn

Dosage and Administration (34068-7)

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistance sunscreen if swimming or sweating
  • 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
  • children under 6 months of age: ask a doctor
Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

NAPLES

SOAP COMPANY

SUNSCREEN

Broad spectrum SPF 15

-15-

Lip Balm

.15 oz / 4.25 g

Peppermint

Distributed by: Naples Soap Company

Fort Myers, FL 33913

naplessoap.com - (239) 325-8263

Made in USA from

foreign & domestic parts - 84489

Section 44425-7 (44425-7)

Other information protect this product from excessive heat and direct sun

Section 50565-1 (50565-1)

Keep out of reach of children

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

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51727-6 (51727-6)

Inactive ingredients

Helianthus Annuus (Sunflower) Seed Oil*, Cera Flava (Beeswax)*, Theobroma Cacao (Cocoa) Seed Butter*, Cocos Nucifera (Coconut) Oil*, Essential Oil of Mentha Piperita (Peppermint) Leaf Oil*, Aloe Barbadensis (Aloe Vera) Leaf Oil*, Mixed Tocopherols (Vitamin E), Rosmarinus Officinalis (Rosemary) Leaf Extract*, Calendula Officinalis (Calendula) Flower Extract*. *Organic Ingredient

Section 51945-4 (51945-4)

Net Wt. 0.15 oz (4.25 g)

Section 53413-1 (53413-1)

Questions or comments?

Questions? 1-888-256-8265 or visit www.naplessoap.com

Section 55105-1 (55105-1)

Purpose:

Sunscreen

Section 55106-9 (55106-9)

Active ingredients

Avobenzone 3%, Octinoxate 7.5%, Octisalate 5%, Octocrylene 5%


Advanced Ingredient Data


Raw Label Data

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