Coppertone waterBABIES Pure and Simple Free

Manufacturer
Bayer HealthCare LLC.
Effective date
2019-11-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:57:18

Label at a glance#

ProductCoppertone waterBABIES Pure and Simple Free SPF 50
Active ingredientHOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATE, OXYBENZONE
Label structure13 sections

Dosage and administration

• 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 Specturm SPF value of 15 or higher and other sun protection measures including: • lim...

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

Avobenzone 3%, Homosalate 15%, Octisalate 5%,

Octocrylene 10%, Oxybenzone 6%.............................Sunscreen

Use

OTC - PURPOSE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

When Using this Product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if a rash occurs

Keep out of reach of children.

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

• 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 Specturm SPF value of 15 or higher and other sun protection measures including: • limit the 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

• protect this product from excessive heat and direct sun • may stain or damage some fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Butylene Glycol, Microcrystalline Cellulose, Behenyl Alcohol, Glyceryl Stearate, Benzyl Alcohol, Palmitic Acid, Stearic Acid, Tocopherol (Vitamin E), Myristyl Alcohol, Cellulose Gum, Butylated PVP, Chlorphenesin, Lecithin, Cetyl Alcohol, Lauryl Alcohol, Disodium EDTA, Sodium Ascorbyl Phosphate

Questions?

OTC - QUESTIONS SECTION

Questions? 1-866-288-3330

Label 6 oz.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New Look

Coppertone®

SUNSCREEN LOTION

water

babies®

Pure & Simple

No Frangrance,

Parabens, PABA 50

Water Resistant

(80 Minutes)

Broad Spectrum

SPF 50

6 FL OZ (177 mL)

6 oz bottle label6 oz bottle label

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-740911523-7409-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 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
9831dfa5-728e-4157-e053-2a95a90a1bd15421971d-83e6-2aec-e054-00144ff8d46c2019-11-25WarningsExact identifier
spl id: 9831dfa5-728e-4157-e053-2a95a90a1bd1
spl set id: 5421971d-83e6-2aec-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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