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 47 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neutrogena Ultra Gentle Daily Facial Moisturizer Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAcupac Packaging, Inc.4ef669b9-df00-8965-e063-6394a90ab3352026-04-08WarningsExact identifier
application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAcupac Packaging, Inc.4ef6a60a-6634-e79b-e063-6394a90a3daa2026-04-08WarningsExact identifier
application number: M020
Neutrogena Mineral Invisible Daily Defense Face Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef6b5fb-5495-001c-e063-6394a90ab7b32026-04-08WarningsExact identifier
application number: M020
Sunright Lip BalmOCTINOXATE, AVOBENZONE, AND OCTOCRYLENENSE Products, Inc.dfdb2d0a-c646-4c44-b648-e2fdd604cdc92026-04-08WarningsExact identifier
application number: M020
Nu Colour Bioadaptive BB Plus Foundation - Light GoldenTITANIUM DIOXIDENSE Products, Inc.faae6f47-19f3-41cb-8e0d-388569b5c73d2026-04-07WarningsExact identifier
application number: M020
Ultra SunscreenOCTINOXATE, OCTISALATE, TITANIUM DIOXIDEJiangsu Senwo Medical Technology Co., Ltd.4ed974b8-6c11-08e0-e063-6294a90a77132026-04-07WarningsExact identifier
application number: M020
Vivaiodays SPF 30 Sunscreen with TurmericSPF 30 SUNSCREEN WITH TURMERIC5SENCO INC4ee0c93a-7f50-2bda-e063-6294a90abff42026-04-07WarningsExact identifier
application number: M020
Neutrogena MINERAL UV TINT FACE MEDIUM DEEP SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc4ee39bbf-b7d7-8f87-e063-6294a90a25392026-04-07WarningsExact identifier
application number: M020
BEVERLY HILLS MD SHEER RADIANCE SPF DROPS SUNSCREENZINC OXIDEBeverly Hills MD, LLC4ed34743-cc68-501b-e063-6294a90ad3962026-04-07WarningsExact identifier
application number: M020
Nu Colour Bioadaptive BB plus Foundation - BeigeTITANIUM DIOXIDENSE Products, Inc.f74e83fe-41a0-4998-ae53-30ed5af475922026-04-07WarningsExact identifier
application number: M020
Thinksport SPF 30ZINC OXIDEthinkOperations,LLC33065919-9b4e-4b2b-9306-a706558241c82026-04-07WarningsExact identifier
application number: M020
Nutricentials Day Dream ProtectiveHOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENENSE Products, Incdaca8347-f7e7-4733-bd22-1da7a6076fad2026-04-06WarningsExact identifier
application number: M020
TONEfitSUN Ultra Moisturizing Vegan SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory4ec58c23-16b1-03bb-e063-6394a90a46c02026-04-06WarningsExact identifier
application number: M020
Dior Forever Velvet Veil 24H Mattifying Makeup Base Blurring-Smoothing Pore Refining Effect with Sunscreen SPF 15HOMOSALATE, OCTISALATE, OCTOCRYLENEParfums Christian Diorbe36b83f-662d-49c6-a12f-a64e11721d0c2026-04-06WarningsExact identifier
application number: M020
Pure SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELiz Corporation Ltd4eca5257-6840-2a33-e063-6394a90ade282026-04-06WarningsExact identifier
application number: M020
Dior Forever Skin Veil 24H Glow Hydrating Base Plumping and Smoothing Effect Hyaluronic Acid with Sunscreen SPF 25ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENEParfums Christian Dior4a5147f3-4e52-447a-a89c-058aea8a612c2026-04-06WarningsExact identifier
application number: M020
Simple Mineral Sunscreen SPF 50ZINC OXIDESimple Sunscreen LLCc38cb4fa-8b8d-4c2d-9c32-301e120db1a12026-04-06WarningsExact identifier
application number: M020
Badger SPF 50 Adventure Sport Mineral Sunscreen CreamZINC OXIDEW.S. Badger Company, Inc.2a96c423-f4ad-0f07-e063-6394a90a39f82026-04-06WarningsExact identifier
application number: M020
Sheer Touch Sunscreen SPF 55AVOBENZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC03fce792-bcbb-4848-bc87-8913ecbe07862026-04-06Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC8937705d-b745-4b8c-bf9b-89e64a1e52b12026-04-06Warnings, Adverse reactionsExact 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