FDA.reportPublic FDA data

CoralSafe Broad Spectrum SPF30

Product NDC
71221-333
11-digit product format
712210333
Labeler code
71221
Product ID
71221-333_09d8bb51-cbef-deeb-e063-6394a90a7a60
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE, ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Elements Brands
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-06-01
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
60; 60 mg/L; mg/L
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
CoralSafe Broad Spectrum SPF30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE60 mg/L
ZINC OXIDE60 mg/L

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
e6e00896-b7e5-41c6-a72b-08e600758cf5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71221-333-00CoralSafe Broad Spectrum SPF303.78 L in 1 JUGCREAM3.782
71221-333-00CoralSafe Broad Spectrum SPF301 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71221-333CORALSAFE BROAD SPECTRUM SPF30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ELEMENTS BRANDS]2Current NDC, Legacy NDC, 2 package rows20231111_e6e00896-b7e5-41c6-a72b-08e600758cf5.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 77 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 6W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior03c7ca69-86f1-420c-9c4c-0bf2e8553c942026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 7N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorff6a85a4-b0c5-4c2e-a698-bb315203f51b2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 7W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior262b4cfc-71c3-485e-906f-a88fe33035a82026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 8N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior30964b87-1d7c-4dd1-8ab2-bf9b8eb2ee032026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 9N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior2cb4bad3-57d6-4e67-88ec-1776870c3eba2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 00 NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorffd1ba9e-dd64-422a-bd69-596b5d80554d2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 00,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior64943a01-5193-4c04-b623-33ceb09f10fd2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 0N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diordf2e2d3f-8876-4197-bdfa-339b4f6a75712026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 0,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6cb5d7fa-4d40-46bd-9ef3-14368578cb332026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 0CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorae1e74f1-eb31-4da1-8b24-dae692d3637e2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 0W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diora5ce5568-708a-4af1-aa06-ea643c898bb12026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4fc4ce51-000a-42ee-952f-b4ce5f5d8a602026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorade16145-5267-4f01-bd99-f507087583f32026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4b23d8e4-b0c3-44d7-b239-a2c7ae442a2d2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior72471612-1ae0-493c-87c7-bf7257310e702026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior881ad126-d93f-4782-8ece-600d41a254d72026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior27bb6424-9aa6-408a-a9f4-874cb60c8f1f2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorea170049-ec16-4c9d-a73d-368f6b747d572026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb6fb14f0-a3e3-4545-bb4a-f9c27190b11b2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6cb14dcf-8b70-40c3-882b-063d8922ce4c2026-01-16WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71221-333-00712210333001 JUG in 1 CARTON (71221-333-00) / 3.78 L in 1 JUG1 jug2018-06-010000-00-00NoNoCurrent