INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50

Product NDC
16555-008
11-digit product format
165550008
Labeler code
16555
Product ID
16555-008_26a76872-0814-5d6f-e063-6394a90aa63e
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE and ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
DARPHIN DIST.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-07-15
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
63; 40 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE63 mg/mL
ZINC OXIDE40 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
16555-008-01INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF5030 mL in 1 BOTTLELOTION309
16555-008-01INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF501 in 1 CARTONLOTION19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16555-008INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [DARPHIN DIST.]9Current NDC, Legacy NDC, 2 package rows20241114_91277514-4db0-4b40-b95a-3530cac711df.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16555-008-01165550008011 BOTTLE in 1 CARTON (16555-008-01) / 30 mL in 1 BOTTLE1 bottle2017-07-150000-00-00NoNoCurrent