FDA.reportPublic FDA data

Sport Face Mineral Lotion SPF 50 UI 1613641

Manufacturer
Bayer HealthCare LLC.
Effective date
2019-12-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:54:38

Label at a glance#

ProductCoppertone Sport Face Mineral SPF 50
Active ingredientOCTISALATE, ZINC OXIDE, OCTINOXATE
Label structure10 sections

Indications and 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

Dosage and administration

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 p...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

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

OTC - PURPOSE SECTION

Purpose

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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 SECTION

Warnings
For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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 SAFETY INFORMATION

Other information

■ protect this product from excessive heat and direct sun

■ may stain or damage some fabrics or surfaces

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions? 1-866-288-3330

Package display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

Product labelProduct label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-747311523-7473-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
DICAPRYLYL ETHER77JZM5516ZIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIMETHICONE92RU3N3Y1OIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIB
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)5Z4DPO246AIACT
YELLOW WAX2ZA36H0S2VIACT
BENZYL ALCOHOLLKG8494WBHIACT
CHLORPHENESINI670DAL4SZIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
GLYCERINPDC6A3C0OXIACT
TRILAURETH-4 PHOSPHATEM96W2OLL2VIACT
OCTINOXATE4Y5P7MUD51ACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
994b634b-6735-21f8-e053-2995a90a53ac91180f4d-22d6-652c-e053-2995a90af44d2019-12-09WarningsExact identifier
spl id: 994b634b-6735-21f8-e053-2995a90a53ac
spl set id: 91180f4d-22d6-652c-e053-2995a90af44d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.