FDA.reportPublic FDA data

Essential Defense Everyday Clear Broad Spectrum SPF 47 Sunscreen

Product NDC
0023-5738
11-digit product format
000235738
Labeler code
0023
Product ID
0023-5738_96f07d78-f324-41ce-8954-4e9bea77c277
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide and Octinoxate
Dosage form
LOTION
Route
TOPICAL
Labeler
Allergan, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-03-16
Substance
ZINC OXIDE; OCTINOXATE
Active strength
120; 75 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Essential Defense Everyday Clear Broad Spectrum SPF 47 Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE120 mg/g
OCTINOXATE75 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
bc872876-20e7-40cb-b79d-68998883681aAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0023-5738-182021-11-15ESSENTIAL DEFENSE EVERYDAY CLEAR BROAD SPECTRUM SPF 47 SUNSCREEN- zinc oxide and octinoxate lotion Allergan, Inc. Drug Facts
0023-5738-182021-11-15ESSENTIAL DEFENSE EVERYDAY CLEAR BROAD SPECTRUM SPF 47 SUNSCREEN- zinc oxide and octinoxate lotion Allergan, Inc. Drug Facts
0023-5738-252021-11-15ESSENTIAL DEFENSE EVERYDAY CLEAR BROAD SPECTRUM SPF 47 SUNSCREEN- zinc oxide and octinoxate lotion Allergan, Inc. Drug Facts
0023-5738-252021-11-15ESSENTIAL DEFENSE EVERYDAY CLEAR BROAD SPECTRUM SPF 47 SUNSCREEN- zinc oxide and octinoxate lotion Allergan, Inc. Drug Facts
0023-5738-182021-07-23ESSENTIAL DEFENSE EVERYDAY CLEAR BROAD SPECTRUM SPF 47 SUNSCREEN- zinc oxide and octinoxate lotion Allergan, Inc. Drug Facts
0023-5738-182021-07-23ESSENTIAL DEFENSE EVERYDAY CLEAR BROAD SPECTRUM SPF 47 SUNSCREEN- zinc oxide and octinoxate lotion Allergan, Inc. Drug Facts
0023-5738-252021-07-23ESSENTIAL DEFENSE EVERYDAY CLEAR BROAD SPECTRUM SPF 47 SUNSCREEN- zinc oxide and octinoxate lotion Allergan, Inc. Drug Facts
0023-5738-252021-07-23ESSENTIAL DEFENSE EVERYDAY CLEAR BROAD SPECTRUM SPF 47 SUNSCREEN- zinc oxide and octinoxate lotion Allergan, Inc. Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0023-5738-18Essential Defense Everyday Clear Broad Spectrum SPF 47 Sunscreen52.5 g in 1 TUBELOTION52.55
0023-5738-18Essential Defense Everyday Clear Broad Spectrum SPF 47 Sunscreen1 in 1 CARTONLOTION15
0023-5738-25Essential Defense Everyday Clear Broad Spectrum SPF 47 Sunscreen7.1 g in 1 TUBELOTION7.15
0023-5738-25Essential Defense Everyday Clear Broad Spectrum SPF 47 Sunscreen6 in 1 CARTONLOTION65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-5738ESSENTIAL DEFENSE EVERYDAY CLEAR BROAD SPECTRUM SPF 47 SUNSCREEN (ZINC OXIDE AND OCTINOXATE) LOTION [ALLERGAN, INC.]5Current NDC, Legacy NDC, 4 package rows20231228_bc872876-20e7-40cb-b79d-68998883681a.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 53 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sei Bella Tinted BB Moisturizing Cream115 NMelaleuca Inc.2f132cc0-e8e3-35e3-e063-6394a90a4f3d2026-03-17WarningsExact identifier
application number: M020
Tinted Sunscreen Broad SPF30TINTED SUNSCREEN BROAD SPF30DOSCHER FAMILY HEALTH NP P.C.4d4021ba-4b29-6b81-e063-6294a90a5ea72026-03-17WarningsExact identifier
application number: M020
SOME BY MI TRUECICA AQUA CALMING SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPERENNEBELL Co., Ltd.4d42d5aa-d12e-1086-e063-6294a90a12df2026-03-17WarningsExact identifier
application number: M020
GOODAL HEARTLEAF SOOTHING QUICK SLIDING SUNSCREEN StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECLIO COSMETICS Co., Ltd.bce6008b-3dab-44e4-9a07-d996bf652d072026-03-17WarningsExact identifier
application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 23ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4d206947-1e89-7ef1-e063-6394a90a7d072026-03-16WarningsExact identifier
application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 25ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4d207687-b58f-916d-e063-6394a90a737f2026-03-16WarningsExact identifier
application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 31ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4d20a060-fedd-d2f2-e063-6294a90a5cc02026-03-16WarningsExact identifier
application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 27ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4d210edf-0966-87c8-e063-6394a90a30c72026-03-16WarningsExact identifier
application number: M020
Advanced Formula Lip Balm SPF 25 Blood OrangeAVOBENZONE, OCTINOXATEAnthony Skin LLC74853b40-a773-4488-98a9-c8029ad211342026-03-16WarningsExact identifier
application number: M020
Advanced Formula Lip Balm SPF 25AVOBENZONE, OCTINOXATEAnthony Skin LLC74d7bc30-db15-4cfc-8918-40897d54da702026-03-16WarningsExact identifier
application number: M020
CVS SPF 70 Sport Face SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS26e66240-97ae-103d-e063-6394a90a9b5a2026-03-16WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 45AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beierdorf Incf2a06097-b066-8631-e053-2a95a90a9ffc2026-03-16WarningsExact identifier
application number: M020
Ultra Light Invisible SPF 40 sunscreenHOMOSALATE 8%, OCTISALATE 5.0%, AVOBENZONE 3.0%, OCTOCRYLENE 4.0%RK Shea LLC02d59d96-0edb-472c-b730-148a2eb4fa4a2026-03-16WarningsExact identifier
application number: M020
TIRTIR SUN BOUNCY GLOW LIP BALM SPF 30 SOFT SANDZINC OXIDECOSMAX USA4d31038e-a032-3ce9-e063-6394a90a889d2026-03-16WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Face Serum Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC4ce3d79b-fec5-8501-e063-6294a90a479d2026-03-15WarningsExact identifier
application number: M020
Neutrogena Invisible Daily Defense Face Serum Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC4ce59571-132a-c633-e063-6294a90a8d972026-03-15WarningsExact identifier
application number: M020
Neutrogena Clear Face Serum Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC4ce63abb-e716-40de-e063-6394a90a6e762026-03-15WarningsExact identifier
application number: M020
GOODAL HEARTLEAF SOOTHING MOISTURE SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECLIO COSMETICS Co., Ltd.8d147089-709f-4468-a47d-9251e737c9a42026-03-15WarningsExact identifier
application number: M020
Cay Skin Isle Lip Balm SPF 30AVOBENZONE, HOMOSALATE, OCTISALATECay Skin, Inc.d92a17c4-9827-5fb1-e053-2a95a90a9ca12026-03-13WarningsExact identifier
application number: M020
DAILY FACE SUNSCREEN Broad Spectrum SPF 30ZINC OXIDELilyana Naturals LLCe5f53e2f-6566-4eac-b9b5-7697abaf044b2026-03-13WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0023-5738-18000235738181 TUBE in 1 CARTON (0023-5738-18) / 52.5 g in 1 TUBE1 tube2016-03-160000-00-00NoNoCurrent
0023-5738-25000235738256 TUBE in 1 CARTON (0023-5738-25) / 7.1 g in 1 TUBE6 tube2016-03-160000-00-00NoNoCurrent