FDA.reportPublic FDA data

Coppertone Defend and Clear

Product NDC
66800-3641
11-digit product format
668003641
Labeler code
66800
Product ID
66800-3641_4746b4ab-5851-7572-e063-6394a90a971d
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Octisalate, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Beiersdorf Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-11-02
Substance
OCTINOXATE; OCTISALATE; ZINC OXIDE
Active strength
7.5; 4.5; 9.7 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Coppertone Defend and Clear
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE4.5 g/100g
ZINC OXIDE9.7 g/100g
OCTINOXATE7.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
SOI2LOH54ZInternal UNII lookup
4Y5P7MUD51Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
baaec6a9-2c60-2d11-e053-2a95a90abca7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66800-3641-3Coppertone Defend and Clear88 g in 1 TUBELOTION886
66800-3641-6Coppertone Defend and Clear177 g in 1 TUBELOTION1776

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66800-3641COPPERTONE DEFEND AND CLEAR (OCTINOXATE, OCTISALATE, ZINC OXIDE) LOTION [BEIERSDORF INC]5Current NDC, Legacy NDC, 2 package rows20241116_baaec6a9-2c60-2d11-e053-2a95a90abca7.zip

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 361 · 7,215 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
application number: M020
Juyasuyon Sport Ultra Sunscreen CreamOCTOCRYLENE,OXYBENZONE,AVOBENZONE,BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINEGuangdong Aimu Biological Technology Co., Ltd598cfe9e-6ebe-ad18-e063-6294a90ace222026-08-25WarningsExact identifier
application number: M020
NeoStrata Sheer Hydration Sunscreen Broad Spectrum SPF 40OCTINOXATE, OCTISALATE, AND AVOBENZONENeoStrata Company Inc.e8cdf9f7-d968-42b3-bcb8-02dee7717fd82026-08-25WarningsExact identifier
application number: M020
JUYASUYON Sport Ultra SunscreenAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEGuangdong Aimu Biological Technology Co., Ltd59d97ee0-e416-53e7-e063-6294a90a91532026-08-25WarningsExact identifier
application number: M020
NeoStrata Enlighten Skin Brightener with Sunscreen Broad Spectrum SPF 35OCTINOXATE, OCTISALATE, AND AVOBENZONENeoStrata Company Inc.ed495f18-2f8e-4991-b797-82e9f6fc7acb2026-08-25WarningsExact identifier
application number: M020
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID WATERY SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEISNTREE Inc.59e9279a-2427-d6bc-e063-6394a90ae86e2026-08-25WarningsExact identifier
application number: M020
Exuviance Age Reverse Day Repair with Sunscreen Broad Spectrum SPF 30AVOBENZONE, OCTINOXATE, AND OCTISALATENeoStrata Company Inc.4739e678-ce51-4863-bb74-2275879e1b472026-08-24WarningsExact identifier
application number: M020
MELAO zinc stick(YELLOW)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c3009b-ae16-52e1-e063-6394a90a69ee2026-08-24WarningsExact identifier
application number: M020
MELAO zinc stick(PINK)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c68d9b-9aa9-4996-e063-6394a90a48d42026-08-24WarningsExact identifier
application number: M020
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
application number: M020
MELAO zinc stick(BLUE)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c78929-9df7-5212-e063-6394a90a37662026-08-24WarningsExact identifier
application number: M020
Dr Marvel COLOR CHANGING FOUNDATION SPF30ETHYLHEXYL METHOXYCINNAMATEGuangzhou Liyan Cosmetics Technology Co., Ltd.59c8865f-ccee-dd50-e063-6294a90aa1852026-08-24WarningsExact identifier
application number: M020
Exuviance Daily Corrector with Sunsreen Broad Spectrum SPF 35OCTINOXATE, OCTISALATE, AND AVOBENZONENeoStrata Company Inc.74a998e2-8ebf-436c-aac1-b456cd2e072d2026-08-24WarningsExact identifier
application number: M020
Homosalate, Octisalate, Zinc oxideHOMOSALATE, OCTISALATE, ZINC OXIDEAldi Inc59cbfb14-d9b1-ce93-e063-6394a90ac3122026-08-24Warnings, Adverse reactionsExact identifier
application number: M020
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID WATERY SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEISNTREE Inc.59ac747a-f9c7-2c18-e063-6394a90a23062026-08-23WarningsExact identifier
application number: M020
Sunski Sol Power Daily Face Sunscreen SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEStewart Charley Ventures, LLCb6c3d6b1-3d8a-43c0-aac5-07fe60afbd8c2026-08-21WarningsExact identifier
application number: M020
Sunski Hot Block Mineral Sunscreen Stick SPF 50ZINC OXIDEStewart Charley Ventures LLC dba Sunski04ecc5e7-0d9e-4bc7-b964-4cbcc6ed06a82026-08-21WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE, HOMOSALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC5990fe66-4fa2-06aa-e063-6294a90a52612026-08-21WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66800-3641-36680036410388 g in 1 TUBE (66800-3641-3) 88 g2020-11-020000-00-00NoNoCurrent
66800-3641-666800364106177 g in 1 TUBE (66800-3641-6) 177 g2020-11-020000-00-00NoNoCurrent