CAMERA READY

Product NDC
10348-002
11-digit product format
103480002
Labeler code
10348
Product ID
10348-002_94e364ba-9e7c-41f8-864d-dd3d70b2f24b
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXlATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
SMASHBOX BEAUTY COSMETICS, INC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-05-01
Marketing end
0000-00-00
Substance
OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE
Active strength
8 mL/100mL; mL/100mL; mL/100mL; mL/100mL
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10348-002-012020-01-31C16284748780-19d75b9d0-a957-f424-e053-dadaa90a57ce1137a998-539c-4271-b092-990e9ef6f2e7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10348-002-01CAMERA READY5 IN 1 BEAUTY BALM SPF 351 in 1 CARTONLIQUID12
10348-002-02CAMERA READY5 IN 1 BEAUTY BALM SPF 3530 mL in 1 TUBELIQUID302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51CAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
OCTISALATEACTIVE INGREDIENT4X49Y0596WCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
OCTINOXATEACTIVE MOIETY4Y5P7MUD51CAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
OCTISALATEACTIVE MOIETY4X49Y0596WCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
OXYBENZONEACTIVE MOIETY95OOS7VE0YCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
ACETYL HEXAPEPTIDE-3INACTIVE INGREDIENTL4EL31FWILCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0CAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0CAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
APPLEINACTIVE INGREDIENTB423VGH5S9CAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RACAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
CAFFEINEINACTIVE INGREDIENT3G6A5W338ECAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
CHOLESTEROLINACTIVE INGREDIENT97C5T2UQ7JCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
CUCUMBERINACTIVE INGREDIENTYY7C30VXJTCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
DOCOSANOLINACTIVE INGREDIENT9G1OE216XYCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
GAMMA ORYZANOLINACTIVE INGREDIENTSST9XCL51MCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4CAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62CAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
LINOLEIC ACIDINACTIVE INGREDIENT9KJL21T0QJCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
MICAINACTIVE INGREDIENTV8A1AW0880CAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
OCTYLDODECYL NEOPENTANOATEINACTIVE INGREDIENTX8725R883TCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
OCTYLDODECYL STEAROYL STEARATEINACTIVE INGREDIENT3D47Q6D93CCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
PEG-40 STEARATEINACTIVE INGREDIENTECU18C66Q7CAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZGCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4RCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
POLYMETHYLSILSESQUIOXANE (11 MICRONS)INACTIVE INGREDIENTZ570VEV8XKCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
PROPYLENE GLYCOL MONOLAURATEINACTIVE INGREDIENTM4AW13H75TCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
PROPYLENE GLYCOL MONOSTEARATEINACTIVE INGREDIENTF76354LMGRCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
SCUTELLARIA BAICALENSIS ROOTINACTIVE INGREDIENT7J95K7ID2SCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
SODIUM DEHYDROACETATEINACTIVE INGREDIENT8W46YN971GCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A2CAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
SORBITAN MONOLAURATEINACTIVE INGREDIENT6W9PS8B71JCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
SQUALANEINACTIVE INGREDIENTGW89575KF9CAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
SUCROSEINACTIVE INGREDIENTC151H8M554CAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
TREHALOSEINACTIVE INGREDIENTB8WCK70T7ICAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
UREAINACTIVE INGREDIENT8W8T17847WCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
WATERINACTIVE INGREDIENT059QF0KO0RCAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
WHEAT GERMINACTIVE INGREDIENTYR3G369F5ACAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10348-002CAMERA READY 5 IN 1 BEAUTY BALM SPF 35 (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]2Legacy NDC, 2 package rows20110705_1137a998-539c-4271-b092-990e9ef6f2e7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
10348-002-01103480002011 in 1 CARTONHistorical
10348-002-021034800020230 mL in 1 TUBE30 mlHistorical