FDA.reportPublic FDA data

PRIMEROSE WHITE MILKY CB

Product NDC
69888-103
11-digit product format
698880103
Labeler code
69888
Product ID
69888-103_7f898b2d-7112-94d7-e053-2991aa0adc48
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone, Niacinamide, Panthenol, Adenosine
Dosage form
CREAM
Route
TOPICAL
Labeler
Royal Springs Cosmetics USA, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-02-13
Marketing end
0000-00-00
Substance
DIMETHICONE; NIACINAMIDE; PANTHENOL; ADENOSINE
Active strength
0 1/80mL; 1/80mL; 1/80mL; 1/80mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69888-103-022020-09-27C16284748780-1ab0e2407-30dc-f274-e053-dbdaa90a6471PRIMEROSE WHITE MILKY CB CREAM
69888-103-022020-09-25C16284748780-1ab0e2407-30dc-f274-e053-dbdaa90a6471PRIMEROSE WHITE MILKY CB CREAM
69888-103-022020-07-22C16284748780-1ab0e2407-30dc-f274-e053-dbdaa90a6471PRIMEROSE WHITE MILKY CB CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69888-103-01PRIMEROSE WHITE MILKY CB80 mL in 1 BOTTLECREAM808
69888-103-02PRIMEROSE WHITE MILKY CB1 in 1 PACKAGECREAM18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ADENOSINEACTIVE INGREDIENTK72T3FS567PRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OPRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
NIACINAMIDEACTIVE INGREDIENT25X51I8RD4PRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
PANTHENOLACTIVE INGREDIENTWV9CM0O67ZPRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
ADENOSINEACTIVE MOIETYK72T3FS567PRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
DIMETHICONEACTIVE MOIETY92RU3N3Y1OPRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
NIACINAMIDEACTIVE MOIETY25X51I8RD4PRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
PANTHENOLACTIVE MOIETYWV9CM0O67ZPRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0PRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
AllantoinINACTIVE INGREDIENT344S277G0ZPRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XPRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
BetaineINACTIVE INGREDIENT3SCV180C9WPRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAPRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
Caprylyl GlycolINACTIVE INGREDIENT00YIU5438UPRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
CERAMIDE 3INACTIVE INGREDIENT4370DF050BPRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
CETYL DIMETHICONE 45INACTIVE INGREDIENTIK315POC44PRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
Cetyl ethylhexanoateINACTIVE INGREDIENT134647WMX4PRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)INACTIVE INGREDIENTV2W71V8T0XPRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RPRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BAPRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)INACTIVE INGREDIENTUF7620L1W6PRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGVPRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXPRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4PRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
GLYCYRRHIZINATE DIPOTASSIUMINACTIVE INGREDIENTCA2Y0FE3FXPRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THPRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
IsohexadecaneINACTIVE INGREDIENT918X1OUF1EPRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
MACADAMIA OILINACTIVE INGREDIENT515610SU8CPRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1EPRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HPRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YPRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
SqualaneINACTIVE INGREDIENTGW89575KF9PRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPPRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2
WaterINACTIVE INGREDIENT059QF0KO0RPRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69888-103PRIMEROSE WHITE MILKY CB (DIMETHICONE, NIACINAMIDE, PANTHENOL, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]8Legacy NDC, 2 package rows20190118_d22d0785-c0c8-4c6b-b088-9f4f9435e49b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
69888-103-016988801030180 mL in 1 BOTTLE80 mlHistorical
69888-103-02698880103021 in 1 PACKAGEHistorical