Coppertone Pure & Simple Lotion SPF 50 UI 1613993

Manufacturer
Bayer HealthCare LLC.
Effective date
2019-12-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:55:09

Label at a glance#

ProductCoppertone Pure and Simple SPF 50
Active ingredientZINC OXIDE
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 each 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 ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Zinc Oxide 24.08%

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 each 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, C12-15 alkyl benzoate, isopropyl palmitate, butyloctyl salicylate, ethylhexyl isononanoate, cetyl PEG/PPG-10/1 dimethicone, propylene glycol, cyclopentasiloxane, bis-octyldodecyl dimer dilinoleate/propanediol copolymer, dimethicone, ethylhexyl methoxycrylene, polyester-27, tea (camellia sinensis) leaf extract*, giant kelp (macrocystis pyrifera) extract*, sacred lotus (nelumbo nucifera) extract*, triethoxycaprylysilane, beeswax, hydroxyacetophenone, PEG-12 dimethicone crosspolymer, tocopherol, 1,2-hexanediol, caprylyl glycol, sodium chloride

OTC - QUESTIONS SECTION

Questions? 1-866-288-3330

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New
Coppertone®
SUNSCREEN LOTION
Pure &
Simple
+ 100% natural botanicals*
Tear Free
Hypoallergenic & Gentle 50
Zinc Oxide Protection
No PABA, Parabens, Phthalates,
Fragrances, Dyes, Oxybenzone
Water Resistant (80 Minutes)
Broad Spectrum SPF 50
6 FL OZ (177 mL)

Label Pure and simple 6 oz.Label Pure and simple 6 oz.

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-745811523-7458-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Source Document#

Source XML · Source PDF

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
9907e6ce-116c-5fc0-e053-2995a90a8eea8fef7bf4-7606-bfac-e053-2995a90a8dd32019-12-06WarningsExact identifier
spl id: 9907e6ce-116c-5fc0-e053-2995a90a8eea
spl set id: 8fef7bf4-7606-bfac-e053-2995a90a8dd3

Reported adverse events (FAERS/openFDA)#

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