FDA.reportPublic FDA data

Limited Edition Spray SPF 50

Manufacturer
Beiersdorf Inc
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:30:36

Label at a glance#

ProductCoppertone Limited Edition Sunscreen SPF 50
Active ingredientOCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE
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

■ shake well before each use ■ spray liberally and spread evenly by hand 15 minutes before sun exposure ■ hold container 4 to 6 inches from the skin to apply ■ do not spray directly into face. Spray on hands then apply to face. ■ do not apply in windy conditions ■ use in a well-ventilated area ■ reapply: ■ after 80 minutes of swimming or sweating ■ immediately after towel drying ■ at least every 2 hours ■ Sun Prot...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

(To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%

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
Flammable:Do not use near heat, flame, or while smoking

OTC - DO NOT USE SECTION

Do not useon damaged or broken skin

OTC - WHEN USING SECTION

When using this product
■ keep away from face to avoid breathing it

■ keep out of eyes. Rinse with water to remove.

■ use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

■ do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120˚F.

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

■ shake well before each use

■ spray liberally and spread evenly by hand 15 minutes before sun exposure

■ hold container 4 to 6 inches from the skin to apply

■ do not spray directly into face. Spray on hands then apply to face.

■ do not apply in windy conditions

■ use in a well-ventilated area

■ 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

■ store between 20˚ to 25˚C (68˚ to 77˚F)

■ may stain or damage some fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

SD alcohol 40-B (73.8% v/v), isobutane, neopentyl glycol dipheptanoate, polyester-27, acrylates/octylacrylamide copolymer, dimethicone, fragrance, ascorbyl palmitate

Questions?

OTC - QUESTIONS SECTION

1-866-288-3330

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Limited Edition

Coppertone ®Sunscreen Spray 50

Protects against damaging UVA/UVB rays

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

NET WT 1.6 OZ (45 g)

LE Spray SPF 50LE Spray SPF 50

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix20006382439408_20006382_CT_SPF50_1-6oz_Can_Clean.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66800-4354-1Coppertone Limited Edition Sunscreen SPF 5045 g in 1 CANAEROSOL, SPRAY455

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66800-435466800-4354-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
FRAGRANCE FLORAL ORC0902236R66Z4YW3X0IACT
ALCOHOL3K9958V90MIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
POLYESTER-70841698D2FIACT
ACRYLATES CROSSPOLYMER-64GXD0Q3OS3IACT
DIMETHICONE92RU3N3Y1OIACT
ASCORBYL PALMITATEQN83US2B0NIACT
ISOBUTANEBXR49TP611IACT
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
Coppertone Limited Edition Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incccbf7795-e153-1a43-e053-2a95a90ad4b62025-12-31WarningsExact identifier
ndc (package): 66800-4354-1
ndc (product): 66800-4354
ndc11 (package): 66800435401
spl id: 4746c5d9-23ac-2750-e063-6294a90a0564
spl set id: ccbf7795-e153-1a43-e053-2a95a90ad4b6

Reported adverse events (FAERS/openFDA)#

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