FDA.reportPublic FDA data

Pure & Simple Light Lotion SPF 50

Manufacturer
Beiersdorf Inc
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:30:39

Label at a glance#

ProductCoppertone Waterbabies Pure and Simple Sunscreen SPF 50
Active ingredientOCTOCRYLENE, AVOBENZONE, OCTISALATE, HOMOSALATE
Label structure13 sections

Indications and 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

■ 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: ■ li...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 9%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

■ 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

For external use only

OTC - DO NOT USE SECTION

Do not useon damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor ifrash 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

■ 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

SPL UNCLASSIFIED SECTION

■ protect this product from excessive heat and direct sun

■ may stain or damage some fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, C12-15 alkyl benzoate, neopentyl glycol diheptanoate, styrene/acrylates copolymer, butylene glycol, VP/Eicosene copolymer, 1,2-hexanediol, hydroxyacetophenone, aloe barbadensis leaf juice,

tocopherol, acrylates/C10-30 alkyl acrylate crosspolymer, potassium hydroxide,

disodium EDTA, sodium ascorbyl phosphate

Questions?

OTC - QUESTIONS SECTION

1-866-288-3330

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Coppertone ®Sunscreen Lotion

Waterbabies Light Lotion

SPF50

Formulated with Vitamin E

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

6 FL OZ (177 mL)

WB Light Lotion US_ChinaWB Light Lotion US_China

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130072140034436GTIN-13: 0072140034436
EAN-13: 0072140034436
GTIN-12: 072140034436
UPC-A: 072140034436
GTIN storage (14 digits): 00072140034436		WB Light Lotion US_China.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66800-4839-6Coppertone Waterbabies Pure and Simple Sunscreen SPF 50177 g in 1 TUBELOTION1774

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66800-483966800-4839-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)5Z4DPO246AIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
TOCOPHEROLR0ZB2556P8IACT
ACRYLATES CROSSPOLYMER-64GXD0Q3OS3IACT
DISODIUM EDTA-COPPER6V475AX06UIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
EICOSYL POVIDONEXQQ9MKE2BJIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ALOE VERA LEAFZY81Z83H0XIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
HOMOSALATEV06SV4M95SACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3d471b8-7430-98b0-e053-2995a90aba4b2025-12-31WarningsExact identifier
ndc (package): 66800-4839-6
ndc (product): 66800-4839
ndc11 (package): 66800483906
spl id: 4746d39e-9b7b-38bb-e063-6294a90ad596
spl set id: d3d471b8-7430-98b0-e053-2995a90aba4b
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3e66496-bc3c-d189-e053-2a95a90a06b62025-12-31WarningsExact identifier
ndc (product): 66800-4839

Reported adverse events (FAERS/openFDA)#

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