Tropical Sands, SPF-50 Broad Spectrum Sunscreen

Product NDC
71221-794
11-digit product format
712210794
Labeler code
71221
Product ID
71221-794_09daf79f-48f2-ee9b-e063-6294a90a2833
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
2017-02-22
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

Additional Listing Data#

Finished product
Yes
Brand name base
Tropical Sands, SPF-50 Broad Spectrum Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

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
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71221-794-54Tropical Sands, SPF-50 Broad Spectrum Sunscreen159 mL in 1 BOTTLECREAM1592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71221-794TROPICAL SANDS, SPF-50 BROAD SPECTRUM SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ELEMENTS BRANDS, INC.]2Current NDC, Legacy NDC, 1 package rows20231112_493551d0-10a0-3d78-e054-00144ff8d46c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71221-794-5471221079454159 mL in 1 BOTTLE (71221-794-54) 159 ml2017-02-220000-00-00NoNoCurrent