COPPERTONE SPORT FACE MINERAL SPF 50- octinoxate, octisalate, zinc oxide lotion

Coppertone Sport Face Mineral SPF 50 by

Drug Labeling and Warnings

Coppertone Sport Face Mineral SPF 50 by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients

Octinoxate 7.5%, Octisalate 4.5%, Zinc Oxide 9.7%

PURPOSE

Purpose

Sunscreen

Uses

Uses

■ helps prevent sunburn

■ if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

WARNINGS

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions

■ shake well before use

■ apply liberally 15 minutes before sun exposure

■ reapply:

■ after 80 minutes of swimming or sweating

■ immediately after towel drying

■ at least every 2 hours

■ 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-sleeve shirts, pants, hats, and sunglasses

■ children under 6 months: Ask a doctor

Other information

Other information

■ protect this product from excessive heat and direct sun

■ may stain or damage some fabrics or surfaces

INACTIVE INGREDIENT

Inactive ingredients water, dicaprylyl ether, glycerin, polyester-27, styrene/acrylates copolymer, trilaureth-4 phosphate, cetearyl alcohol, beeswax, dimethicone, ammonium acryloyldimethyltaurate/vp copolymer, benzyl alcohol, glyceryl stearate, triethoxycaprylylsilane, chlorphenesin, disodium EDTA

QUESTIONS

Questions? 1-866-288-3330

Package display

Coppertone®

SUNSCREEN LOTION

SPORT

FACE™

Mineral Based Protection

Stays on Strong

Won't Run into Eyes

50

No Dyes, PABA, Oxybenzone

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

2.5 FL OZ (74 mL)

INGREDIENTS AND APPEARANCE

COPPERTONE SPORT FACE MINERAL SPF 50 
octinoxate, octisalate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7473
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	97 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
YELLOW WAX (UNII: 2ZA36H0S2V)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCERIN (UNII: PDC6A3C0OX)
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	yellow (off white to light yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-7473-1	74 mL in 1 TUBE; Type 0: Not a Combination Product	02/01/2019	09/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2019	09/01/2021

Labeler - Bayer HealthCare LLC. (112117283)