SUN CARE SPF 30 FACESTICK SPF 30- avobenzone, octinoxate, octisalate, oxybenzone stick

Sun Care SPF 30 Facestick by

Drug Labeling and Warnings

Sun Care SPF 30 Facestick by is a Otc medication manufactured, distributed, or labeled by Naples Soap Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients

Avobenzone 3%, Octinoxate 7.5%, Octisalate 5%, Oxybenzone 4%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Usehelps prevent sunburn

WARNINGS

Warnings

Do not useon damaged or broken skin

When using this product,keep out of eyes

Stop use and ask a doctor ifrash occurs

Keep out of reach of children.

DOSAGE & ADMINISTRATION

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 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

STORAGE AND HANDLING

Other informationprotect this product from excessive heat and direct sun

INACTIVE INGREDIENT

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

Questions or comments?239-325-8263 or visit www.naplessoap.com

SPL UNCLASSIFIED SECTION

SPF 30

NAPLES

SOAP COMPANY

NATURALLY BETTER

SKIN CARE

SUN CARE

Broad Spectrum Sunscreen

SPF 30

Face Stick

0.56 oz (17g)

Distributed by Naples Soap Company,FL 33913

Questions? 239-325-8263 or

visit www.naplessoap.com

Made in the U.S.A. with Imported Ingredients

Net Wt. .56 oz (17g) Peel here for drug facts

PRINCIPAL DISPLAY PANEL

Net Wt. .56 oz (17 g)

INGREDIENTS AND APPEARANCE

SUN CARE SPF 30 FACESTICK  SPF 30
avobenzone, octinoxate, octisalate, oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84489-166
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ROSEMARY OIL (UNII: 8LGU7VM393)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
YELLOW WAX (UNII: 2ZA36H0S2V)
SUNFLOWER OIL (UNII: 3W1JG795YI)
COCOA BUTTER (UNII: 512OYT1CRR)
TOCOPHEROL (UNII: R0ZB2556P8)
COCONUT OIL (UNII: Q9L0O73W7L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84489-166-01	17 g in 1 TUBE; Type 0: Not a Combination Product	05/21/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/21/2021

Labeler - Naples Soap Co. (052273536)