Coppertone Defend & Care Ultra Hydrate Lotion SPF 50

Manufacturer
Bayer HealthCare LLC.
Effective date
2019-07-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:04:23

Label at a glance#

ProductCoppertone Defend and Care Ultra Hydrating SPF 50
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Label structure14 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...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Avobenzone 3%, Homosalate 10%, Octisalate 4.55%,

Octocrylene 9 %, Oxybenzone 5%

Purpose

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

WARNINGS SECTION

Warnings

For external use only

Do not use

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.

Stop use

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, aluminum starch octenylsuccinate, dimethicone, ethylhexyl isononanoate, styrene/acrylates copolymer, glycerin, octyldodecanol,

Galactoarabinan, silica, glyceryl stearate, peg-100 stearate, benzyl alcohol, triethanolamine, acrylates/C10-30 alkyl acrylate crosspolymer,tocopherol (vitamin E), Beeswax, Chlorphenesin, disodium EDTA, sodium ascorbyl phosphate, fragrance

Questions

OTC - QUESTIONS SECTION

Questions? 1-866-288-3330

Bottle 177 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-738811523-7388-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

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
8ed6fb4d-a000-1373-e053-2a95a90a4a435a2baa54-664f-3bd0-e053-2a91aa0a5f892019-07-29WarningsExact identifier
spl id: 8ed6fb4d-a000-1373-e053-2a95a90a4a43
spl set id: 5a2baa54-664f-3bd0-e053-2a91aa0a5f89

Reported adverse events (FAERS/openFDA)#

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