Even Tone Mineral Sunscreen Broad Spectrum SPF 40 Light - Medium

Product NDC
71398-013
11-digit product format
713980013
Labeler code
71398
Product ID
71398-013_f358e12d-767c-487e-9e6d-e9e91e4d1e71
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide and Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
SENT�, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-06-10
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
47.43; 87.048 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Even Tone Mineral Sunscreen Broad Spectrum SPF 40 Light - Medium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE47.43 mg/mL
ZINC OXIDE87.048 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71398-013-01Even Tone Mineral Sunscreen Broad Spectrum SPF 40 Light - Medium50 mL in 1 TUBELOTION503
71398-013-01Even Tone Mineral Sunscreen Broad Spectrum SPF 40 Light - Medium1 in 1 CARTONLOTION13
71398-013-02Even Tone Mineral Sunscreen Broad Spectrum SPF 40 Light - Medium8 mL in 1 TUBELOTION83
71398-013-02Even Tone Mineral Sunscreen Broad Spectrum SPF 40 Light - Medium1 in 1 CARTONLOTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71398-013EVEN TONE MINERAL SUNSCREEN BROAD SPECTRUM SPF 40 LIGHT - MEDIUM (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [SENTÉ, INC.]2Current NDC, Legacy NDC, 4 package rows20240415_417305d7-d32e-4bc9-8f77-0a42b6bdecf5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71398-013-01713980013011 TUBE in 1 CARTON (71398-013-01) / 50 mL in 1 TUBE1 tube2022-06-100000-00-00NoNoCurrent
71398-013-02713980013021 TUBE in 1 CARTON (71398-013-02) / 8 mL in 1 TUBE1 tube2022-06-100000-00-00NoNoCurrent