FDA.reportPublic FDA data

Coral Safe SPF-30 Broad Spectrum Sunscreen

Product NDC
71221-792
11-digit product format
712210792
Labeler code
71221
Product ID
71221-792_09d8c273-4504-2a49-e063-6394a90a3a09
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE, ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Elements Brands, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-02-21
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
60; 60 mg/mL; mg/mL
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
Coral Safe SPF-30 Broad Spectrum Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

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

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
4925a3ad-6379-108a-e054-00144ff8d46cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71221-792-08Coral Safe SPF-30 Broad Spectrum Sunscreen236 mL in 1 BOTTLECREAM2362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71221-792CORAL SAFE SPF-30 BROAD SPECTRUM SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ELEMENTS BRANDS, INC.]2Current NDC, Legacy NDC, 1 package rows20231111_4925a3ad-6379-108a-e054-00144ff8d46c.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 215 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Broad Spectrum SPF45ZINC OXIDE, OCTINOXATEDrmtlgy, LLCce93b371-26ab-4493-98e0-98234c3a9ba62025-05-01WarningsExact identifier
application number: M020
Winter Rescue KitOCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEDUKE CANNON SUPPLY CO.24356548-348d-2cd2-e063-6294a90ab3522025-04-29WarningsExact identifier
application number: M020
Prequel Lip Visor SPF 30 CLEARLIP 30 CLEARThe Center Brands, LLC33d5d1d4-c516-238c-e063-6294a90ac11c2025-04-28WarningsExact identifier
application number: M020
LBEL DEFENSE TOTAL SUNSCREEN FOR FACE AND BODY SPF 50AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBEL STAR SA33db89ac-2653-78f5-e063-6394a90af03d2025-04-28WarningsExact identifier
application number: M020
LifeguardSUNSCREENSPHERE 8 INC32be4eb3-f106-182d-e063-6394a90aa4842025-04-28WarningsExact identifier
application number: M020
Practical Alchemy Purify and Protect DuoMICELLAR WATER WIPES AND ZINC OXIDEOver Here, LLC28514e58-59a6-094a-e063-6394a90a1c7d2025-04-28WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 PorcelainOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS2fbf7f9d-dba7-48f9-b10e-63225e8f13992025-04-25WarningsExact identifier
application number: M020
BEEF TALLOW SUNSCREENZINC OXIDEYunqi Cosmetics (Shenzhen) Co., Ltd3380a271-1538-2e3a-e063-6294a90a90a22025-04-24WarningsExact identifier
application number: M020
BEEF TALLOW SUNSCREENZINC OXIDEYunqi Cosmetics (Shenzhen) Co., Ltd3380f1ac-0320-35f2-e063-6394a90a97eb2025-04-24WarningsExact identifier
application number: M020
BEEF TALLOW SUNSCREENZINC OXIDE 15%Yunqi Cosmetics (Shenzhen) Co., Ltd33813fe1-8496-d541-e063-6294a90a62542025-04-24WarningsExact identifier
application number: M020
Sunstation Sport Sunscreen SPF 30OCTISALATE, OCTOCRYLENE, ZINC OXIDEImpact Melanoma Incba78aa73-a25b-4a8e-99b2-9262bb9a7d272025-04-24WarningsExact identifier
application number: M020
Olay Age Defying Anti-Wrinkle Day Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company42819c8d-cc0a-4bee-95db-39a69ce7f6602025-04-24WarningsExact identifier
application number: M020
LBEL FOREVER MATTE LONGWEAR AND CONTROL FOUNDATION 72H SPF 15 CHAMPAGNE 170NOCTINOXATE, ZINC OXIDEBEL STAR S.A.338c2c66-497a-f7d1-e063-6294a90a77892025-04-24WarningsExact identifier
application number: M020
The Ordinary UV Filters SPF 45 SerumHOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATEDeciem10cde253-26ee-b97d-e063-6394a90a83022025-04-23WarningsExact identifier
application number: M020
BareBack sunscreen SPF50 infused with Hyaluronic acid and vitamin CZINC OXIDEVeganicSKN3123aab6-0407-19e5-e063-6394a90a5bd82025-04-23WarningsExact identifier
application number: M020
Sephora Daily Sunscreen Cream Broad Spectrum SPF 30ZINC OXIDES+b49e043b-8164-421c-a02b-3dab0be1454d2025-04-22WarningsExact identifier
application number: M020
YAYA Organics SPF-50 Sports CreamZINC OXIDEYAYA ORGANICS L.L.C.9eabf1f8-698b-4fa8-98d3-3696c35b044c2025-04-22WarningsExact identifier
application number: M020
YAYA Organics SPF-50 Baby Kids Mineral SunscreenZINC OXIDEYAYA ORGANICS L.L.C.3275303d-a448-4fb4-bdce-6442823f89962025-04-22WarningsExact identifier
application number: M020
Oathology Inzincable Sunscreen SPF 50HOMOSALATE, OCTOCRYLENE, ZINC OXIDESKINOATH LLCd245dfca-9e32-4e71-9df8-58fff84ef6a92025-04-22WarningsExact identifier
application number: M020
Back9ine Skincare Pure Invisible Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBack 9ine Skincare, LLC974ede40-cfb5-4612-b168-5d42dd137f632025-04-22WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71221-792-0871221079208236 mL in 1 BOTTLE (71221-792-08) 236 ml2017-02-210000-00-00NoNoCurrent