FDA.reportPublic FDA data

Titanium Dioxide and Zinc oxide - Allergan, Inc.

Manufacturer
Allergan, Inc.
Effective date
2025-10-09
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
monthly-update
Hydrated at
2026-07-17 21:35:44

Label at a glance#

ProductEssential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen
Active ingredientTitanium Dioxide, Zinc oxide
Label structure9 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

apply liberally 15 minutes before sun exposure reapply at least every 2 hours   use a water resistant sunscreen if swimming or sweating Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging.   To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:   limit time in the sun, espe...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 5.0%

Zinc Oxide 6.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin 

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove. 

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs 

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours 
  • use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures.
    Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: 
  • limit time in the sun, especially from 10 a.m.-2 p.m.
  • wear long sleeved shirts, pants, hats, and sunglasses
  • children under 6 months of age: Ask a doctor

Other information

OTHER SAFETY INFORMATION

  • protect the product in this container from excessive heat and direct sun
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Cyclopentasiloxane, Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Butylene Glycol, Aluminum Hydroxide, Dimethicone/PEG-10/15 Crosspolymer, PEG-9 Polydimethylsiloxyethyl Dimethicone, Sodium Chloride, Caffeine, Camellia Oleifera Leaf Extract, Sodium Citrate, Dimethicone/Vinyl Dimethicone Crosspolymer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Stearic Acid, Ethylhexylglycerin, Phenoxyethanol

Principal Display Panel - Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0023-5703-17

SKINMEDICA®
Essential

Defense
Mineral Shield

Broad Spectrum

SPF 35
Sunscreen

50 ml / 1.7 fl. oz. U.S.

NDC 0023-5703-17 SKINMEDICA® Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen 50 ml / 1.7 fl. oz. U.S.NDC 0023-5703-17 SKINMEDICA® Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen 50 ml / 1.7 fl. oz. U.S.

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0023-5703-082021-11-12C16284748780-1c7ccaba7-1d25-fd44-e053-dadaa90aa01bESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35 SUNSCREEN Titanium dioxide and zinc oxide lotion Drug Facts
0023-5703-082021-11-12C16284748780-1c7ccaba7-1d25-fd44-e053-dadaa90aa01bESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35 SUNSCREEN Titanium dioxide and zinc oxide lotion Drug Facts
0023-5703-172021-11-12C16284748780-1c7ccaba7-1d25-fd44-e053-dadaa90aa01bESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35 SUNSCREEN Titanium dioxide and zinc oxide lotion Drug Facts
0023-5703-172021-11-12C16284748780-1c7ccaba7-1d25-fd44-e053-dadaa90aa01bESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35 SUNSCREEN Titanium dioxide and zinc oxide lotion Drug Facts
0023-5703-252021-11-12C16284748780-1c7ccaba7-1d25-fd44-e053-dadaa90aa01bESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35 SUNSCREEN Titanium dioxide and zinc oxide lotion Drug Facts
0023-5703-252021-11-12C16284748780-1c7ccaba7-1d25-fd44-e053-dadaa90aa01bESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35 SUNSCREEN Titanium dioxide and zinc oxide lotion Drug Facts
0023-5703-082021-07-23C16284748780-1c7ccaba7-1d25-fd44-e053-dadaa90aa01bESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35 SUNSCREEN Titanium dioxide and zinc oxide lotion Drug Facts
0023-5703-082021-07-23C16284748780-1c7ccaba7-1d25-fd44-e053-dadaa90aa01bESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35 SUNSCREEN Titanium dioxide and zinc oxide lotion Drug Facts
0023-5703-172021-07-23C16284748780-1c7ccaba7-1d25-fd44-e053-dadaa90aa01bESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35 SUNSCREEN Titanium dioxide and zinc oxide lotion Drug Facts
0023-5703-172021-07-23C16284748780-1c7ccaba7-1d25-fd44-e053-dadaa90aa01bESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35 SUNSCREEN Titanium dioxide and zinc oxide lotion Drug Facts
0023-5703-252021-07-23C16284748780-1c7ccaba7-1d25-fd44-e053-dadaa90aa01bESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35 SUNSCREEN Titanium dioxide and zinc oxide lotion Drug Facts
0023-5703-252021-07-23C16284748780-1c7ccaba7-1d25-fd44-e053-dadaa90aa01bESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35 SUNSCREEN Titanium dioxide and zinc oxide lotion Drug Facts

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0023-57030023-5703-17, 0023-5703-08, 0023-5703-25

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Zinc oxideSOI2LOH54ZACTIB
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONE92RU3N3Y1OIACT
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)RLA2U05Z4QIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
DIMETHICONE/PEG-10/15 CROSSPOLYMER21AS8B1BSSIACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
SODIUM CHLORIDE451W47IQ8XIACT
CAFFEINE3G6A5W338EIACT
CAMELLIA OLEIFERA LEAF5077EL0C60IACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONEX75PL53TZJIACT
STEARIC ACID4ELV7Z65APIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62016-03-02full-release2026-06-01 00:05:47

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Essential Defense Mineral Shield Broad Spectrum SPF 35 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEAllergan, Inc.29817fdc-f14c-4013-a8ed-4367f3b2867c2025-10-09WarningsExact identifier
ndc (package): 0023-5703-08
ndc (package): 0023-5703-17
ndc (package): 0023-5703-25
ndc (product): 0023-5703
ndc11 (package): 00023570325
ndc11 (package): 00023570317
ndc11 (package): 00023570308
spl id: e6d10e4e-e74d-4031-a284-0bf0ca07375f
spl set id: 29817fdc-f14c-4013-a8ed-4367f3b2867c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.