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 5 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HAWAIIAN TROPICAVOBENZONE, HOMOSALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC5990fe66-4fa2-06aa-e063-6294a90a52612026-08-21WarningsExact identifier
application number: M020
Hawaiian TropicAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC5991466a-e729-16b7-e063-6394a90a11ff2026-08-21WarningsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC597b78df-83cb-1b21-e063-6294a90a56a82026-08-20Warnings, Adverse reactionsExact identifier
application number: M020
Sunski Base Camp Face and Body Sunscreen SPF 45HOMOSALATE, OCTISALATE, AVOBENZONEStewart Charley Ventures, LLC2fc45f85-a6f8-4893-8b34-4db5e39cb6152026-08-20WarningsExact identifier
application number: M020
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
application number: M020
SunscreenBROAD SPECTRUM SPF 30Concierge Choice LLC5980055b-493e-4763-e063-6294a90a570f2026-08-20WarningsExact identifier
application number: M020
Lip Balm SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENESkin Script, LLC20c5fde7-ee8f-4b74-e063-6394a90a93ec2026-08-19WarningsExact identifier
application number: M020
Aloe UP .5OZ SPF 50 MINERAL SunscreenZINC OXIDE 14.69%Aloe Care International, LLC6ad80af3-78cd-4211-a5f2-68531aae264a2026-08-19WarningsExact identifier
application number: M020
Utu Broad Spectrum SPF 50 Tinted Sunscreen-StickZINC OXIDEUtu Co596e17d3-3064-1cda-e063-6294a90af9632026-08-19WarningsExact identifier
application number: M020
Mineral sunscreenMINERAL SUNSCREENGuangzhou Origin Beauty Cosmetics Co., Ltd.59713657-a7ef-1aee-e063-6394a90a326e2026-08-19WarningsExact identifier
application number: M020
The Naked Bee SPF 50 Mineral SunscreenZINC OXIDE 14.69%The Naked Beef820a9be-c94d-4fd5-b202-2dda5746a82a2026-08-18WarningsExact identifier
application number: M020
The Naked Bee SPF 50 Mineral SunscreenZINC OXIDE 20%The Naked Bee7dd2b1cd-e229-4eeb-8122-46fde5af10912026-08-18WarningsExact identifier
application number: M020
Sun Zapper - Baby pure zinc sunscreen SPF30ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED3ee52faa-64a8-4bdf-e063-6294a90a65cf2026-08-17WarningsExact identifier
application number: M020
Sun Zapper - Face pure zinc sunscreen SPF30ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED3ee4feb3-6966-67f9-e063-6394a90a16d52026-08-17WarningsExact identifier
application number: M020
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
application number: M020
Soleil Defense SunscreenBROAD SPECTRUM SPF 30AMARA MED SPA LLC594244b1-db3b-002b-e063-6394a90a03292026-08-17WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
application number: M020
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
application number: M020
SunscreenBROAD SPECTRUM SPF 30Charleston Dermatology, P.C.59440f7f-4213-6e2b-e063-6394a90af4832026-08-17WarningsExact 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