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 168 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aveeno Positively Radiant Daily Moisturizer Sunscreen Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLCdd9ebc46-0fa4-5d96-e053-2995a90a79182025-11-06WarningsExact identifier
application number: M020
Hawaiian Tropic Mineral Face Skin Nourishing Tinted Milk Coconut Oil SPF30TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCeeb3c173-b280-76e4-e053-2995a90a0e792025-11-06WarningsExact identifier
application number: M020
SPF 50 Sunscreen StickZINC OXIDEELEEO BRANDS LLC09cf0f04-961e-4430-91bb-224e7fed13ef2025-11-06WarningsExact identifier
application number: M020
Hawaiian Tropic Mineral Skin Nourishing Milk Coconut Oil SPF 50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCefcd52c2-4208-46a1-e053-2a95a90a857d2025-11-06WarningsExact identifier
application number: M020
Peachy Mineral Facial SunscreenZINC OXIDEPeachy Corp42efead0-0e11-7270-e063-6394a90a4eb92025-11-06WarningsExact identifier
application number: M020
Peachy Tinted Facial SunscreenZINC OXIDEPeachy Corp42f0fb68-c0bf-cf98-e063-6294a90ab7032025-11-06WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands, LLC764401f3-4219-6e9b-e053-2991aa0a3ed22025-11-06WarningsExact identifier
application number: M020
Banana Boat Sport coolzone Clear Sunscreen Broad Spectrum SPF 30AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCab7102ba-1020-3f51-e053-2995a90ae24d2025-11-06WarningsExact identifier
application number: M020
Banana Boat Sunscreen Lip Balm UVA/UVB Broad Spectrum SPF 45AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCc794592c-d24e-4530-e053-2995a90a7e4d2025-11-06WarningsExact identifier
application number: M020
Green Envee Radiance SheerZINC OXIDEGreen Envee42f1908f-2787-c4e5-e063-6294a90afcd02025-11-06WarningsExact identifier
application number: M020
Indie Lee Daily PrimerZINC OXIDEAmerica Exchange38e5232b-7daf-7e61-e063-6394a90aa5b02025-11-06WarningsExact identifier
application number: M020
Duette UntintedZINC OXIDESkin Theory Studios3ce24b39-8bb1-1246-e063-6294a90a32d42025-11-06WarningsExact identifier
application number: M020
Duette TintedZINC OXIDESkin Theory Studios3ce1d7cb-b37d-fb9f-e063-6394a90aaef32025-11-06WarningsExact identifier
application number: M020
Truskin Broad Spectrum Mineral Sunscreen Facial Serum with Vitamin C and AloeZINC OXIDEAllure Labs42f3999f-4163-fadc-e063-6294a90aacf32025-11-06WarningsExact identifier
application number: M020
Melan RXZINC OXIDEMelan RXf4bdf20c-b6bc-55f1-e053-2995a90ac3082025-11-06WarningsExact identifier
application number: M020
ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FUCSIA CAUTIVANTE EXOTIC) - PINKOCTINOXATE AND OXYBENZONEVentura Corporation LTDe1eb77f1-d65c-4af8-a7d9-90f10570960f2025-11-06WarningsExact identifier
application number: M020
Ultraceuticals Ultra UV Protective Daily MoisturisingZINC OXIDEUltraceuticalsfc8a5c02-23b4-b4d8-e053-6294a90a55ea2025-11-06WarningsExact identifier
application number: M020
Vaihea Protect Clean SPF DropsZINC OXIDEVaihea Skincare LLCfe7e3145-a8e2-d14f-e053-6394a90abb5e2025-11-06WarningsExact identifier
application number: M020
Refy Skin TrioZINC OXIDERefy3029a690-dbb0-ff15-e063-6394a90abdbe2025-11-06WarningsExact identifier
application number: M020
Stream2Sea Broad Spectrum 20TITANIUM DIOXIDEStream2Sea, LLC1775d07d-6914-6928-e054-00144ff88e882025-11-06WarningsExact 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