FDA.reportPublic FDA data

Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen

Product NDC
0023-5703
11-digit product format
000235703
Labeler code
0023
Product ID
0023-5703_e6d10e4e-e74d-4031-a284-0bf0ca07375f
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide and Zinc oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Allergan, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-03-16
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
50; 60 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 Mineral Shield Broad Spectrum SPF 35 Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE50 mg/g
ZINC OXIDE60 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
29817fdc-f14c-4013-a8ed-4367f3b2867cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0023-5703-082021-11-12ESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35 SUNSCREEN Titanium dioxide and zinc oxide lotion Drug Facts
0023-5703-082021-11-12ESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35 SUNSCREEN Titanium dioxide and zinc oxide lotion Drug Facts
0023-5703-172021-11-12ESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35 SUNSCREEN Titanium dioxide and zinc oxide lotion Drug Facts
0023-5703-172021-11-12ESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35 SUNSCREEN Titanium dioxide and zinc oxide lotion Drug Facts
0023-5703-252021-11-12ESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35 SUNSCREEN Titanium dioxide and zinc oxide lotion Drug Facts
0023-5703-252021-11-12ESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35 SUNSCREEN Titanium dioxide and zinc oxide lotion Drug Facts
0023-5703-082021-07-23ESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35 SUNSCREEN Titanium dioxide and zinc oxide lotion Drug Facts
0023-5703-082021-07-23ESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35 SUNSCREEN Titanium dioxide and zinc oxide lotion Drug Facts
0023-5703-172021-07-23ESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35 SUNSCREEN Titanium dioxide and zinc oxide lotion Drug Facts
0023-5703-172021-07-23ESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35 SUNSCREEN Titanium dioxide and zinc oxide lotion Drug Facts
0023-5703-252021-07-23ESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35 SUNSCREEN Titanium dioxide and zinc oxide lotion Drug Facts
0023-5703-252021-07-23ESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35 SUNSCREEN Titanium dioxide and zinc oxide lotion Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0023-5703-08Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen227 g in 1 BOTTLELOTION2276
0023-5703-08Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen1 in 1 CARTONLOTION16
0023-5703-17Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen52.5 g in 1 TUBELOTION52.56
0023-5703-17Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen1 in 1 CARTONLOTION16
0023-5703-25Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen6 in 1 CARTONLOTION66
0023-5703-25Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen7.1 g in 1 TUBELOTION7.16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-5703ESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35 SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [ALLERGAN, INC.]6Current NDC, Legacy NDC, 6 package rows20231228_29817fdc-f14c-4013-a8ed-4367f3b2867c.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 3 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunski Hot Block Mineral Sunscreen Stick SPF 50ZINC OXIDEStewart Charley Ventures LLC dba Sunski04ecc5e7-0d9e-4bc7-b964-4cbcc6ed06a82026-09-01WarningsExact identifier
application number: M020
Sun Wave Anti Aging Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC7e48a3d2-e453-4733-b42b-8bea804cda592026-09-01WarningsExact identifier
application number: M020
Sun Wave Anti Aging Lite SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC7204c24f-aab6-45eb-9bd4-879f715ba0752026-09-01WarningsExact identifier
application number: M020
Sun Wave Anti Aging Lite SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC7c1e780a-1831-4f49-a92e-e36017d241a22026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLCd45614c8-b09c-417b-b691-082ea21498802026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC999b0b17-be73-4d42-b182-ce038f4933012026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLCadffff46-4cfb-4c0a-b1a6-75220ee193a52026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC13b2b45b-70e1-46ff-8555-48e1fe98c6512026-09-01WarningsExact identifier
application number: M020
Sun Wave Kids Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC5c2a5ca3-e9eb-48ba-8698-592d2c7aa2412026-09-01WarningsExact identifier
application number: M020
Sunceutical SPF 50 Mineral Face CreamZINC OXIDEBaxter Laboratories Pty. Ltd.2c408728-a1de-d51e-e063-6294a90ade0b2026-08-31WarningsExact identifier
application number: M020
SKIN1004 MADAGASCAR CENTELLA HYALU-CICA WATER-FIT SUN SERUM UVBUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENECraver Corporation38d8c1c9-86b5-1edd-e063-6394a90aeb472026-08-30WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGELAVOBENZONE, HOMOSALATE, OCTISALATEISNTREE Inc.5a3a17ff-a7fd-f707-e063-6394a90a31822026-08-29WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID NATURAL SUNCREAMZINC OXIDEISNTREE Inc.5a3a59b2-18b6-521b-e063-6294a90a29582026-08-29WarningsExact identifier
application number: M020
Cetaphil Daily Facial Moisturizer with suncreen SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGalderma Laboratories, L.P.f5eb347f-0d46-4de6-8f3f-9010327678ed2026-08-28WarningsExact identifier
application number: M020
Utu Broad Spectrum SPF 30 Moisturizing Body SunscreenZINC OXIDEUtu Co59938ace-c97c-d758-e063-6394a90a77e42026-08-28WarningsExact identifier
application number: M020
Utu Broad Spectrum SPF 30 Moisturizing Face Mineral Zinc Oxide Sunscreen UnscentedZINC OXIDEUtu Co5982e790-7cdb-c96c-e063-6394a90a02d42026-08-28WarningsExact identifier
application number: M020
Utu Hydrating Sun Balm Broad Spectrum SPF 50ZINC OXIDEUtu Co59d1d0ac-2444-d6f9-e063-6294a90ae80c2026-08-28WarningsExact identifier
application number: M020
Hello Bello Mineral Sunscreen SPF 50ZINC OXIDETopiderm, Inc.54f12764-5c37-4a05-bf96-209fedb93fd12026-08-28WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGELAVOBENZONE, HOMOSALATE, OCTISALATEISNTREE Inc.5a02c540-5b3b-9379-e063-6294a90a00f62026-08-27WarningsExact identifier
application number: M020
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0023-5703-08000235703081 BOTTLE in 1 CARTON (0023-5703-08) / 227 g in 1 BOTTLE1 bottle2016-03-160000-00-00NoNoCurrent
0023-5703-17000235703171 TUBE in 1 CARTON (0023-5703-17) / 52.5 g in 1 TUBE1 tube2016-03-160000-00-00NoNoCurrent
0023-5703-25000235703256 TUBE in 1 CARTON (0023-5703-25) / 7.1 g in 1 TUBE6 tube2016-03-160000-00-00NoNoCurrent