FDA.reportPublic FDA data

Sheer Broad Spectrum SPF45

Product NDC
67226-2845
11-digit product format
672262845
Labeler code
67226
Product ID
67226-2845_31f54126-042d-bf61-e063-6394a90a2d39
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE
Dosage form
LOTION
Route
TOPICAL
Labeler
Vivier Pharma Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-05-14
Marketing end
2026-09-30
Substance
OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE
Active strength
75; 50; 80; 99 mg/mL; mg/mL; mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sheer Broad Spectrum SPF45

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE75 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE80 mg/mL
ZINC OXIDE99 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Y5P7MUD51, 4X49Y0596W, 5A68WGF6WM, 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
67226-2845-2Sheer Broad Spectrum SPF45250 mL in 1 TUBELOTION25011
67226-2845-4Sheer Broad Spectrum SPF451 in 1 CARTONLOTION111
67226-2845-4Sheer Broad Spectrum SPF454 mL in 1 TUBELOTION411
67226-2845-9Sheer Broad Spectrum SPF4590 mL in 1 BOTTLELOTION9011
67226-2845-9Sheer Broad Spectrum SPF451 in 1 CARTONLOTION111

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51VIVIERSKIN SHEER BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE) LOTION [VIVIER PHARMA INC.]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WVIVIERSKIN SHEER BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE) LOTION [VIVIER PHARMA INC.]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMVIVIERSKIN SHEER BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE) LOTION [VIVIER PHARMA INC.]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZVIVIERSKIN SHEER BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE) LOTION [VIVIER PHARMA INC.]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51VIVIERSKIN SHEER BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE) LOTION [VIVIER PHARMA INC.]1
OCTISALATEACTIVE MOIETY4X49Y0596WVIVIERSKIN SHEER BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE) LOTION [VIVIER PHARMA INC.]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMVIVIERSKIN SHEER BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE) LOTION [VIVIER PHARMA INC.]1
ZINC CATIONACTIVE MOIETY13S1S8SF37VIVIERSKIN SHEER BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE) LOTION [VIVIER PHARMA INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0VIVIERSKIN SHEER BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE) LOTION [VIVIER PHARMA INC.]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8VIVIERSKIN SHEER BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE) LOTION [VIVIER PHARMA INC.]1
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQVIVIERSKIN SHEER BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE) LOTION [VIVIER PHARMA INC.]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SVIVIERSKIN SHEER BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE) LOTION [VIVIER PHARMA INC.]1
CYCLOMETHICONE 4INACTIVE INGREDIENTCZ227117JEVIVIERSKIN SHEER BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE) LOTION [VIVIER PHARMA INC.]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RVIVIERSKIN SHEER BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE) LOTION [VIVIER PHARMA INC.]1
DOCOSANOLINACTIVE INGREDIENT9G1OE216XYVIVIERSKIN SHEER BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE) LOTION [VIVIER PHARMA INC.]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUVIVIERSKIN SHEER BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE) LOTION [VIVIER PHARMA INC.]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39VIVIERSKIN SHEER BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE) LOTION [VIVIER PHARMA INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TVIVIERSKIN SHEER BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE) LOTION [VIVIER PHARMA INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TVIVIERSKIN SHEER BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE) LOTION [VIVIER PHARMA INC.]1
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4RVIVIERSKIN SHEER BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE) LOTION [VIVIER PHARMA INC.]1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYVIVIERSKIN SHEER BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE) LOTION [VIVIER PHARMA INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHVIVIERSKIN SHEER BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE) LOTION [VIVIER PHARMA INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VIVIERSKIN SHEER BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE) LOTION [VIVIER PHARMA INC.]1
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08EVIVIERSKIN SHEER BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE) LOTION [VIVIER PHARMA INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RVIVIERSKIN SHEER BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE) LOTION [VIVIER PHARMA INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67226-2845SHEER BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE) LOTION [VIVIER PHARMA INC.]11Current NDC, Legacy NDC, 5 package rows20250406_c7f05046-3641-4d7b-8399-f5c7c3e9ed33.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67226-2845-267226284502250 mL in 1 TUBE (67226-2845-2) 250 ml2015-05-140000-00-00NoNoCurrent
67226-2845-4672262845041 in 1 CARTONHistorical
67226-2845-9672262845091 BOTTLE in 1 CARTON (67226-2845-9) / 90 mL in 1 BOTTLE1 bottle2015-05-142026-09-30NoNoCurrent