FDA.reportPublic FDA data

Daily Defence Shield

Product NDC
65912-003
11-digit product format
659120003
Labeler code
65912
Product ID
65912-003_43f52c86-6ac3-110e-e063-6394a90a0d4a
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, OCTINOXATE, and OCTOCRYLENE
Dosage form
CREAM
Route
TOPICAL
Labeler
ELEMIS Limited
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-06-04
Substance
AVOBENZONE; OCTINOXATE; OCTOCRYLENE
Active strength
14; 14; 7 mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Daily Defence Shield
Brand name suffix
SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE14 mg/g
OCTINOXATE14 mg/g
OCTOCRYLENE7 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b2b6de93-47c8-4b6e-9fb9-8bdc8909271aAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
65912-003-412021-08-13Daily Defence Shield SPF 30
65912-003-432021-08-13Daily Defence Shield SPF 30
65912-003-412021-01-29Daily Defence Shield SPF 30
65912-003-432021-01-29Daily Defence Shield SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65912-003-41Daily Defence ShieldSPF 301 in 1 CARTONCREAM18
65912-003-41Daily Defence ShieldSPF 3040 g in 1 TUBECREAM408
65912-003-43Daily Defence ShieldSPF 3040 g in 1 TUBECREAM408
65912-003-52Daily Defence ShieldSPF 3040 g in 1 TUBECREAM408

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65912-003DAILY DEFENCE SHIELD SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [ELEMIS LIMITED]7Current NDC, Legacy NDC, 4 package rows20241215_b2b6de93-47c8-4b6e-9fb9-8bdc8909271a.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 15 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bath and Body Works SPF CoconutAVOBENZONE,HOMOSALATE,OCTISALATEBath & Body Works, Inc.56078491-f7d6-97f7-e063-6394a90a6deb2026-07-07WarningsExact identifier
application number: M020
Natu Botanicals DAILY NATURAL SUNSCREEN SPF 35 Reef safe mineral sunscreen with non-nano zinc oxideZINC OXIDESurprise Enterprise LLC38cf4325-9720-f511-e063-6394a90ad6282026-07-07WarningsExact identifier
application number: M020
Sun Bum Road Tripper - Amazon - Coconut Lip Balm SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC560c0f35-2132-52a6-e063-6394a90a2d242026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 BonnieCIELE LIP AND PROTECT LIPSTICK SPF 60 BONNIEDelicate Cosmetics Inc560d1d19-87a6-179b-e063-6294a90ada5e2026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 KellyCIELE LIP AND PROTECT LIPSTICK SPF 60 KELLYDelicate Cosmetics Inc560df34a-e6da-0792-e063-6394a90a7e712026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 LouLouCIELE LIP AND PROTECT LIPSTICK SPF 60 LOULOUDelicate Cosmetics Inc560e37ae-87c0-39d2-e063-6394a90a2af42026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 CassetteCIELE LIP AND PROTECT LIPSTICK SPF 60 CASSETTEDelicate Cosmetics Inc560e4198-b07c-3d48-e063-6394a90a7be32026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 MargauxCIELE LIP AND PROTECT LIPSTICK SPF 60 MARGAUXDelicate Cosmetics Inc560e47d5-c881-438c-e063-6394a90a30912026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 SaddleCIELE LIP AND PROTECT LIPSTICK SPF 60 SADDLEDelicate Cosmetics Inc560e5de5-1350-4046-e063-6394a90abffa2026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 PuzzleCIELE LIP AND PROTECT LIPSTICK SPF 60 PUZZLEDelicate Cosmetics Inc560e5558-8e46-7736-e063-6294a90acb052026-07-07WarningsExact identifier
application number: M020
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
application number: M020
Sunscreen SPF 50AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5%Worthy Promotional Products1d4be26a-4695-491c-85d1-86824e1cd0292026-07-06WarningsExact identifier
application number: M020
SPF 30 SunscreenHOMOSALATE 10% OCTISALATE 5% AVOBENZONE 3%Coconut Caliente Costa Rica LLC71856cb3-9386-4569-80e4-92826342e3862026-07-06WarningsExact identifier
application number: M020
Stay Ageless SunscreenBROAD SPECTRUM SPF 30TOXFAIRY, LLC55f7e07e-1689-6d38-e063-6294a90a91192026-07-06WarningsExact identifier
application number: M020
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
application number: M020
RR SunHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEUndefined Inc87244432-2967-4145-89cd-11a7567083a32026-07-06WarningsExact identifier
application number: M020
TOCOBO Cotton Airy Sun StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON CO., Ltd.35af90d3-dfe1-30dc-e063-6294a90a10a52026-07-05WarningsExact identifier
application number: M020
MDP PEPTIDE 9 BIO SUN PROHOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANESKINIDEA CO., LTD26db53cd-dd82-8790-e063-6394a90a92b12026-07-03WarningsExact identifier
application number: M020
SPF 50 plus SunscreenTITANIUM DIOXIDE AND ZINC OXIDETheravita LLCd8e276cc-0292-499d-9075-a83a2d3fafcc2026-07-02WarningsExact identifier
application number: M020
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.5880b275-91fc-4589-a076-0e55409425d82026-07-02Warnings, Adverse reactionsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65912-003-41659120003411 TUBE in 1 CARTON (65912-003-41) / 40 g in 1 TUBE1 tube2018-06-040000-00-00NoNoCurrent
65912-003-436591200034340 g in 1 TUBE (65912-003-43) 40 g2018-06-040000-00-00NoNoCurrent
65912-003-526591200035240 g in 1 TUBE (65912-003-52) 40 g2018-06-040000-00-00YesNoCurrent