FDA.reportPublic FDA data

Complete Spray SPF 50

Manufacturer
Beiersdorf Inc
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:30:40

Label at a glance#

ProductCoppertone Complete Sunscreen SPF 50
Active ingredientHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE
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

■ 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 tim...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

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.

■ 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

■ 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

■ avoid long-term storage above 40°C (104°F)

■ may stain or damage some fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

SD alcohol 40-B (73.4% v/v), neopentyl glycol diheptanoate, polyester-27, acrylates/octylacrylamide copolymer, dimethicone, fragrance, ascorbyl palmitate

Questions?

OTC - QUESTIONS SECTION

1-866-288-3330

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Coppertone ®Sunscreen Spray

Complete 50

Proven UVA/UVB Protection

+ Moisturizes All Day

+Feels Lightweight

Free of Oxybenzone, Octinoxate, Dyes & PABA

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

Complete Spray 50Complete Spray 50

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130072140035204GTIN-13: 0072140035204
EAN-13: 0072140035204
GTIN-12: 072140035204
UPC-A: 072140035204
GTIN storage (14 digits): 00072140035204		Complete Spray 50 .jpg
Data codeData Matrix10013069Complete Spray 50 .jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66800-0096-5Coppertone Complete Sunscreen SPF 50156 g in 1 CANSPRAY1562

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66800-009666800-0096-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASCORBYL PALMITATEQN83US2B0NIACT
POLYESTER-70841698D2FIACT
FRAGRANCE FRESH CITRUS FLORAL ORC1501495OU4GI2R2WBIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
ALCOHOL3K9958V90MIACT
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW)JU3XHR8VWKIACT
DIMETHICONE92RU3N3Y1OIACT
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB

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 Complete Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incd475e14f-dab1-dec5-e053-2995a90aef732025-12-31WarningsExact identifier
ndc (package): 66800-0096-5
ndc (product): 66800-0096
ndc11 (package): 66800009605
spl id: 4746fc7b-88be-f0df-e063-6394a90ae408
spl set id: d475e14f-dab1-dec5-e053-2995a90aef73

Reported adverse events (FAERS/openFDA)#

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