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

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 Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

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

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