BALANCE DYNAMICS BALANCING

Product NDC
68828-150
11-digit product format
688280150
Labeler code
68828
Product ID
68828-150_3a483673-b894-4efe-9021-5c10cdd637ee
Type
HUMAN OTC DRUG
Nonproprietary name
OCTISALATE OXYBENZONE OCTINOXATE
Dosage form
LOTION
Route
TOPICAL
Labeler
JAFRA COSMETICS INTERNATIONAL
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-04-24
Marketing end
0000-00-00
Substance
OCTISALATE; OXYBENZONE; OCTINOXATE
Active strength
4 g/100mL; g/100mL; g/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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68828-150-122020-01-31C16284748780-19d75b9d0-037c-f424-e053-dadaa90a57ceBALANCE DYNAMICS BALANCING LOTION SPF-15
68828-150-172020-01-31C16284748780-19d75b9d0-037c-f424-e053-dadaa90a57ceBALANCE DYNAMICS BALANCING LOTION SPF-15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68828-150-12BALANCE DYNAMICS BALANCINGSPF 151 in 1 BOXLOTION11
68828-150-17BALANCE DYNAMICS BALANCINGSPF 157 mL in 1 TUBELOTION71
68828-150-62BALANCE DYNAMICS BALANCINGSPF 1550 mL in 1 BOTTLELOTION501

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
OCTISALATEACTIVE MOIETY4X49Y0596WBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
BIOSACCHARIDE GUM-1INACTIVE INGREDIENTBB4PU4V09HBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RABALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995LBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
CENTELLA ASIATICA LEAFINACTIVE INGREDIENT6810070TYDBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
CHONDRUS CRISPUSINACTIVE INGREDIENTOQS23HUA1XBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
DIGLYCERININACTIVE INGREDIENT3YC120743UBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
EDETATE TRISODIUMINACTIVE INGREDIENT420IP921MBBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
GINGERINACTIVE INGREDIENTC5529G5JPQBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
IPOMOEA MAURITIANA TUBERINACTIVE INGREDIENTK67Y2SGX79BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
IRIS GERMANICA VAR. FLORENTINA ROOTINACTIVE INGREDIENTM30XO5X4XDBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZGBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
SACCHARINA LATISSIMA THALLUSINACTIVE INGREDIENT68CMP2MB55BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
SILANETRIOLINACTIVE INGREDIENTE52D0J3TS5BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
TRIBEHENIN PEG-20 ESTERSINACTIVE INGREDIENT84K9EH29Y9BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
WATERINACTIVE INGREDIENT059QF0KO0RBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
WITHANIA SOMNIFERA FLOWERINACTIVE INGREDIENT2HZ95R7082BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
XYLITYLGLUCOSIDEINACTIVE INGREDIENTO0IEZ166FBBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
ZINC SULFATEINACTIVE INGREDIENT89DS0H96TBBALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68828-150BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]1Legacy NDC, 3 package rows20120601_31066ffd-d8be-4390-bc91-268162945de9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68828-150-12688280150121 in 1 BOXHistorical
68828-150-17688280150177 mL in 1 TUBE7 mlHistorical
68828-150-626882801506250 mL in 1 BOTTLE50 mlHistorical