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 55 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EWC Slow Lightweight Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEEWC Ventures, LLC063426b8-d1cf-4ee2-8ab8-ff007227eab82026-03-10WarningsExact identifier
application number: M020
Olay Vitamin C Brightening Facial Moisturizer with Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company4cb268ea-f2b5-ddd1-e063-6394a90a1e962026-03-10WarningsExact identifier
application number: M020
Vacation Grand Cuvee Shimmer SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.e0b3d90b-ba56-43e5-aa68-8e5f473628ff2026-03-09WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique ANTHELIOS UVPRO SPORT INVISIBLE SUNSCREEN BROAD SPECTRUM SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA, Inc.77f46325-600c-40ff-94fc-ea82d43134c22026-03-09WarningsExact identifier
application number: M020
Civant 50 Sunscreen Broad Spectrum SPF 50OCTOCRYLENE, ZINC OXIDECivant LLCe23622b8-49dd-45b9-8c51-1a83181cc7bd2026-03-09WarningsExact identifier
application number: M020
HydroScreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEMETHODIQ INC.4c9d5dfd-d790-fffc-e063-6294a90a4d302026-03-09WarningsExact identifier
application number: M020
Sunsei SPF 45 SunscreenZINC OXIDEShimoda Prime Products, LLC3d48e3e2-18c7-e004-e063-6294a90af4f22026-03-09WarningsExact identifier
application number: M020
Sunsei SPF 30 SunscreenZINC OXIDEShimoda Prime Products, LLC68df620b-7c1c-448c-93fd-91459e393c642026-03-09WarningsExact identifier
application number: M020
EADEM SUNSUEDE DAILY SUNSCREEN AND BLURRING PRIMER SPF50 PLUSAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEADEM, Inc.4ca05e2f-f0c5-821c-e063-6294a90a90b82026-03-09WarningsExact identifier
application number: M020
COOLA SunBlur Primer SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC4c6439e8-abda-663a-e063-6394a90ac43b2026-03-06WarningsExact identifier
application number: M020
COOLA SunBlur Makeup Mist SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC4c666a82-293e-06df-e063-6294a90ad5512026-03-06WarningsExact identifier
application number: M020
No 7 Restore and Renew Multi Action Fragrance Free Day Cream SPF 25AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS4d6d1fda-da78-62ed-e063-6294a90ac1052026-03-06WarningsExact identifier
application number: M020
Palio Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATESole Palio LLC071d5113-8fe8-44bb-8322-542eafc2800a2026-03-05WarningsExact identifier
application number: M020
Olay Age Defying Classic Broad Spectrum SPF 15OCTINOXATE AND ZINC OXIDEThe Procter & Gamble Manufacturing Company4c49dbf1-d1fe-ad4a-e063-6394a90af1512026-03-05WarningsExact identifier
application number: M020
SPF 70 Kids SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDerma Care Research Labs, LLC0aadc378-dc34-9a37-e063-6294a90ad49e2026-03-05WarningsExact identifier
application number: M020
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B50OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION4490f968-46b6-44d2-af2d-5130b52c88612026-03-05WarningsExact identifier
application number: M020
Sunscreen SPF 50SUNSCREEN SPF 50Guangzhou Ariel Biotech Co., Ltd.14b9ec0e-6fff-44b1-e063-6394a90aab972026-03-05WarningsExact identifier
application number: M020
belif Aqua bomb - glow sunstick SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H CO., LTD.4c35fbbc-a79d-318f-e063-6394a90a30a72026-03-04WarningsExact identifier
application number: M020
Kids Mineral Sunscreen Stick SPF 50ZINC OXIDESmalls Brand LLC DBA Roe Wellness4c37855b-08c0-0aa7-e063-6394a90a88422026-03-04WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Incbe03b588-afbd-41d1-be96-444d735c97682026-03-03WarningsExact 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