Total Sun Protection

Product NDC
61352-004
11-digit product format
613520004
Labeler code
61352
Product ID
61352-004_43545da6-6e83-7dc3-e063-6294a90ab889
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Octisalate, Oxybenzone, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Cosmed Dermaceuticals, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-08-01
Substance
OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE
Active strength
75; 30; 30; 40 mg/g; mg/g; mg/g; mg/g
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

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
61352-004-01Total Sun Protection127.6 g in 1 BOTTLE, PLASTICLOTION127.67

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61352-004TOTAL SUN PROTECTION (OCTINOXATE, OCTISALATE, OXYBENZONE, ZINC OXIDE) LOTION [COSMED DERMACEUTICALS, INC.]5Current NDC, Legacy NDC, 1 package rows20241210_dbb16ef1-ab8c-4e71-a2a2-a507d104ff0f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61352-004-0161352000401127.6 g in 1 BOTTLE, PLASTIC (61352-004-01) 127.6 g2018-02-130000-00-00NoNoCurrent