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 131 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Non Tinted Mineral SunscreenZINC OXIDESPECKTRA6 LLC374f063a-1ea6-2fcc-e063-6394a90ac5742025-12-11Exact identifier
application number: M020
Defend Tinted Mineral SPF 40TITANIUM DIOXIDE, ZINC OXIDESMOOTH ESTHETICS LLC36eb9fc0-25d7-cfb4-e063-6394a90a2e222025-12-11Exact identifier
application number: M020
Sheer Tinted Sunscreen SPF40TITANIUM DIOXIDE, ZINC OXIDESIMPLICITY SKIN, SPA & BOUTIQUE, LLC36ebdb85-ce8a-d7e0-e063-6394a90a22612025-12-11Exact identifier
application number: M020
Solar Shield Face and Body SPF 40ZINC OXIDEBRIGHT SKINCARE, LLC3b138432-19e5-e757-e063-6294a90a4cbe2025-12-11WarningsExact identifier
application number: M020
Solar Shield Primer SPF 40ZINC OXIDEBRIGHT SKINCARE, LLC3b149758-bbe1-bd66-e063-6294a90afe782025-12-11WarningsExact identifier
application number: M020
Solar Shield Face and Body SPF 40ZINC OXIDEBRIGHT SKINCARE, LLC3b14caa3-f58e-b9ab-e063-6394a90a96952025-12-11WarningsExact identifier
application number: M020
Solar Shield Primer SPF 40ZINC OXIDEBRIGHT SKINCARE, LLC3b152e27-3917-eb7e-e063-6394a90a1f432025-12-11WarningsExact identifier
application number: M020
Mineral Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDECOLETTE TOMASI LLC3727b29f-fe51-0b15-e063-6394a90a780b2025-12-11Exact identifier
application number: M020
Daytime Moisture SPF40ZINC OXIDECOLETTE TOMASI LLC372773b6-fc37-c74b-e063-6294a90a7bf22025-12-11Exact identifier
application number: M020
Prevention Acne Safe Facial Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDENY BEAUTY PALACE LLC373c291a-7839-8486-e063-6294a90a5af32025-12-11Exact identifier
application number: M020
Prevention BodyZINC OXIDENY BEAUTY PALACE LLC373cef98-a61d-dd36-e063-6394a90a7c3b2025-12-11Exact identifier
application number: M020
Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly TintedZINC OXIDENY BEAUTY PALACE LLC373d1e6c-9c32-20f5-e063-6294a90af86f2025-12-11Exact identifier
application number: M020
Prevention 2 Acne Safe Facial Mineral Sunscreen Non TintedTITANIUM DIOXIDE, ZINC OXIDENY BEAUTY PALACE LLC373c0ab0-8828-542b-e063-6394a90a86332025-12-11Exact identifier
application number: M020
Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly TintedZINC OXIDENY BEAUTY PALACE LLC373ddad0-ed33-a233-e063-6294a90a19cd2025-12-11Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDESKINPLICITY STUDIO LLC37263083-b24f-5a71-e063-6294a90aee7d2025-12-11Exact identifier
application number: M020
Prevention Acne Safe Facial Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDENY BEAUTY PALACE LLC373d4fad-141c-0904-e063-6394a90a97592025-12-11Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDESKINPLICITY STUDIO LLC37265b3d-92ef-ef4a-e063-6294a90a8d952025-12-11Exact identifier
application number: M020
Prevention BodyZINC OXIDENY BEAUTY PALACE LLC373d902f-f7b6-298b-e063-6394a90a93072025-12-11Exact identifier
application number: M020
Nourish And DefendZINC OXIDEANASTASIA FOX-TOMYLOVYCH3726c177-2912-a6cc-e063-6394a90a00432025-12-11Exact identifier
application number: M020
Nourish And DefendZINC OXIDEANASTASIA FOX-TOMYLOVYCH3726f463-7e55-c2a2-e063-6394a90a3c512025-12-11Exact 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