FDA.reportPublic FDA data

PRIMEROSE EGF REPAIRING CREAM

Manufacturer
Royal Springs Cosmetics USA, LLC | Royal Springs Cosmetic Co.,Ltd.
Effective date
2019-01-15
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 22:58:15

Key Label Information#

Active Ingredients And Purpose

Active ingredients

Niacinamide (2%) Dimethicone (1.5%) Adenosine (0.04%)

Purpose

skin protectant

Uses

Uses

Skin brightening and wrinkle care. Keep skin soft and smooth.

Warnings

Warnings

For external use only Do not use when Your skin is red, inflamed, irritated or painful When using this product - Do not apply on other parts of the body - Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. - Do not apply directly to wound or open cut. Stop use and ask doctor if rash or irritation on skin develops and lasts. Store at room temperature

Directions And Dosage

Directions

Apply adequate amount in the palm of hand, softly rub onto face and neck. For dry skin, use Repairing Cream after using Essence Skin.

Other Label Information

Inactive ingredients

Water, Glycerin, Sodium hyaluronate, Butylene Glycol, Neopentyl Glycol Diheptanoate, Cetearyl alcohol, Dimethicone/vinyl dimethicone crosspolymer, Cyclohexasiloxane, Cyclopentasiloxane, Polyacrylate-13, Human oligopeptide-1, Polyglyceryl-3 Methylglucose Distearate, PEG-100 stearate, Glyceryl stearate, Cetyl ethylhexanoate, Sodium Acrylate/Acryloyldimethyltaurate Copolymer, Isohexadecane, Polysorbate 80, Polysorbate-60, Macadamia integrifolia seed oil, Arginine, Phenoxyethanol, Lactobacillus/Portulaca oleracea Ferment Filtrate, Soybean Extract Ferment Filtrate, Punica Granatum Fruit Ferment Extract, Phellius Baumiimycelium, Panax Ginseng Root Ferment Extract Filtrate, Caramel, Beta-glucan, Calcium Pantothenate, Sodium Ascorbyl Phosphate, Pyridoxyne hydrochloride, Maltodextrin, Amylodextrin, Silica, Dipotassium Glycyrrhizate, Sodium EDTA

PRIMEROSE EGF REPAIRING CREAM

Label Images#

egf cream
egf cream

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ADENOSINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69888-102-022020-09-27C16284748780-1ab0e2407-2c94-f274-e053-dbdaa90a6471PRIMEROSE EGF REPAIRING CREAM
69888-102-022020-09-25C16284748780-1ab0e2407-2c94-f274-e053-dbdaa90a6471PRIMEROSE EGF REPAIRING CREAM
69888-102-022020-07-22C16284748780-1ab0e2407-2c94-f274-e053-dbdaa90a6471PRIMEROSE EGF REPAIRING CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69888-102-01PRIMEROSE EGF100 mL in 1 CONTAINERCREAM1008
69888-102-02PRIMEROSE EGF1 in 1 BOXCREAM18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69888-102PRIMEROSE EGF (NIACINAMIDE, DIMETHICONE, ADENOSINE) CREAM [ROYAL SPRINGS COSMETICS USA, LLC]8Legacy NDC, 2 package rows20190118_a0c8db45-e524-4ac0-b83d-e506eb7ba124.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ADENOSINEACTIVE INGREDIENTK72T3FS5674
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1O4
NIACINAMIDEACTIVE INGREDIENT25X51I8RD44
ADENOSINEACTIVE MOIETYK72T3FS5674
DIMETHICONEACTIVE MOIETY92RU3N3Y1O4
NIACINAMIDEACTIVE MOIETY25X51I8RD44
AMYLOPECTININACTIVE INGREDIENT4XO4QFV7774
ArginineINACTIVE INGREDIENT94ZLA3W45F4
ASIAN GINSENGINACTIVE INGREDIENTCUQ3A77YXI4
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RA4
CALCIUM PANTOTHENATEINACTIVE INGREDIENT568ET80C3D4
CARAMELINACTIVE INGREDIENTT9D99G2B1R4
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S4
CETYL ETHYLHEXANOATEINACTIVE INGREDIENT134647WMX44
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R4
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BA4
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)INACTIVE INGREDIENT9E4CO0W6C54
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LU4
GLYCERININACTIVE INGREDIENTPDC6A3C0OX4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE44
GLYCYRRHIZINATE DIPOTASSIUMINACTIVE INGREDIENTCA2Y0FE3FX4
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH4
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1E4
MACADAMIA OILINACTIVE INGREDIENT515610SU8C4
MaltodextrinINACTIVE INGREDIENT7CVR7L4A2D4
Neopentyl Glycol DiheptanoateINACTIVE INGREDIENT5LKW3C543X4
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R4
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T4
POLYACRYLAMIDE (10000 MW)INACTIVE INGREDIENTE2KR9C9V2I4
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4M4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H4
POMEGRANATEINACTIVE INGREDIENT56687D1Z4D4
PYRIDOXINE HYDROCHLORIDEINACTIVE INGREDIENT68Y4CF58BV4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU44
SODIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT836SJG51DR4
WATERINACTIVE INGREDIENT059QF0KO0R4

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69888-10269888-102-01, 69888-102-02

Ingredients#

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
HYALURONATE SODIUMYSE9PPT4THIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
CYCLOMETHICONE 6XHK3U310BAIACT
CYCLOMETHICONE 50THT5PCI0RIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
PEG-100 STEARATEYD01N1999RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETYL ETHYLHEXANOATE134647WMX4IACT
ISOHEXADECANE918X1OUF1EIACT
POLYSORBATE 806OZP39ZG8HIACT
POLYSORBATE 60CAL22UVI4MIACT
MACADAMIA OIL515610SU8CIACT
ARGININE94ZLA3W45FIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ASIAN GINSENGCUQ3A77YXIIACT
POMEGRANATE56687D1Z4DIACT
CARAMELT9D99G2B1RIACT
CALCIUM PANTOTHENATE568ET80C3DIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
MALTODEXTRIN7CVR7L4A2DIACT
AMYLOPECTIN4XO4QFV777IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
EDETATE SODIUMMP1J8420LUIACT
NIACINAMIDE25X51I8RD4ACTIB
DIMETHICONE92RU3N3Y1OACTIB
ADENOSINEK72T3FS567ACTIB

Complete SPL Sections#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Niacinamide (2%) Dimethicone (1.5%) Adenosine (0.04%)

Purpose

OTC - PURPOSE SECTION

skin protectant

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children - Do not swallow. In case of accidental ingestion, seek professional assistance.

Uses

INDICATIONS & USAGE SECTION

Skin brightening and wrinkle care. Keep skin soft and smooth.

Warnings

WARNINGS SECTION

For external use only Do not use when Your skin is red, inflamed, irritated or painful When using this product - Do not apply on other parts of the body - Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. - Do not apply directly to wound or open cut. Stop use and ask doctor if rash or irritation on skin develops and lasts. Store at room temperature

Directions

DOSAGE & ADMINISTRATION SECTION

Apply adequate amount in the palm of hand, softly rub onto face and neck. For dry skin, use Repairing Cream after using Essence Skin.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Sodium hyaluronate, Butylene Glycol, Neopentyl Glycol Diheptanoate, Cetearyl alcohol, Dimethicone/vinyl dimethicone crosspolymer, Cyclohexasiloxane, Cyclopentasiloxane, Polyacrylate-13, Human oligopeptide-1, Polyglyceryl-3 Methylglucose Distearate, PEG-100 stearate, Glyceryl stearate, Cetyl ethylhexanoate, Sodium Acrylate/Acryloyldimethyltaurate Copolymer, Isohexadecane, Polysorbate 80, Polysorbate-60, Macadamia integrifolia seed oil, Arginine, Phenoxyethanol, Lactobacillus/Portulaca oleracea Ferment Filtrate, Soybean Extract Ferment Filtrate, Punica Granatum Fruit Ferment Extract, Phellius Baumiimycelium, Panax Ginseng Root Ferment Extract Filtrate, Caramel, Beta-glucan, Calcium Pantothenate, Sodium Ascorbyl Phosphate, Pyridoxyne hydrochloride, Maltodextrin, Amylodextrin, Silica, Dipotassium Glycyrrhizate, Sodium EDTA

PRIMEROSE EGF REPAIRING CREAM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML