BROAD SPECTRUM SPF 30 FACE STICK SUNSCREEN- avobenzone, octinoxate, octisalate, and oxybenzone stick

Broad Spectrum SPF 30 Face Stick Sunscreen by

Drug Labeling and Warnings

Broad Spectrum SPF 30 Face Stick Sunscreen by is a Otc medication manufactured, distributed, or labeled by Naples Soap Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 3%

Octinoxate 7.5%

Octisalate 5%

Octocrylene 5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn

Warnings

For external use only

• Do not use on damaged or broken skin

• When using this product keep out of eyes. Rinse with water to remove.

• Stop use and ask a doctor if rash occurs

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

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water resistant 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 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

Other information

• Protect this product from excessive heat and direct sun

Inactive ingredients

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

*Organic Ingredient

Questions or Comments?

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

PRINCIPAL DISPLAY PANEL

NAPLES SOAP COMPANY

SUNSCREEN

Broad Spectrum SPF 30

Face Stick

INGREDIENTS AND APPEARANCE

BROAD SPECTRUM SPF 30 FACE STICK SUNSCREEN 
avobenzone, octinoxate, octisalate, and oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84489-779
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
YELLOW WAX (UNII: 2ZA36H0S2V)
TOCOPHEROL (UNII: R0ZB2556P8)
ROSEMARY (UNII: IJ67X351P9)
COCOA BUTTER (UNII: 512OYT1CRR)
SUNFLOWER OIL (UNII: 3W1JG795YI)
COCONUT OIL (UNII: Q9L0O73W7L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84489-779-92	17 g in 1 CYLINDER; Type 0: Not a Combination Product	02/16/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/16/2021

Labeler - Naples Soap Company, Inc. (052273536)