FDA.reportPublic FDA data

THERetinolcream

Manufacturer
Shenzhen XiaoMai Manufacturing Co., Ltd.
Effective date
2024-04-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:06:53

Label at a glance#

ProductTHERetinolcream
Active ingredientTHEOBROMA GRANDIFLORUM SEED BUTTER, CERAMIDE NP, PALMITOYL TETRAPEPTIDE-7, LAVANDULA ANGUSTIFOLIA FLOWER, BERTHOLLETIA EXCELSA FLOWER, EUTERPE OLERACEA WHOLE, CARROT SEED OIL, PUNICA GRANATUM FLOWER, TOCOPHEROL, ASCORBIC ACID, RETINOL, HYALURONIC ACID, MATRICARIA RECUTITA FLOWERING TOP, ROSMARINUS OFFICINALIS FLOWER
Label structure12 sections

Indications and uses

Indications: IMPROVE SKIN QUALITY AND REDUCE WRINKLES AND FINE LINES. PROMOTE A YOUTHFUL APPEARANCE AND EVEN SKIN TONE. REDUCE DARK SPOTS, PIGMENTATION, AND UNEVEN SKIN TONE.

Dosage and administration

Twice daily, in the morning and evening. Recommended usage amount: A pea to cherry-sized amount (about 2-3 grams) is sufficient for each use.

Storage and handling

Store in a cool, dry place, avoid direct sunlight.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Retinol: 1%
Hyaluronic Acid: 1%
Ceramide NP: 1%
Palmitoyl Tetrapeptide-7: 1%
Ascorbic Acid: 2%
Tocopherol: 1.5%
Theobroma Grandiflorum Seed Butter: 1%
Snail Secretion Filtrate: 2%
Chamomilla Recutita (Matricaria) Flower Extract: 1%
Lavandula Angustifolia (Lavender) Flower Extract: 1%
Rosmarinus Officinalis (Rosemary) Leaf Extract: 1%
Punica Granatum Extract: 1%
Euterpe Oleracea Fruit Oil: 1%
Bertholletia Excelsa Seed Oil: 1%
Daucus Carota Sativa (Carrot) Seed Oil: 1%
Soluble Collagen: 2%
Aloe Barbadensis Leaf Juice: 2%
Camellia Sinensis Leaf Extract: 1%
Peptides: 1%
Palmitoyl Oligopeptide: 1.5%

PURPOSE

OTC - PURPOSE SECTION


PURPOSE
To improve skin quality, reduce wrinkles, enhance skin elasticity and firmness, and promote a youthful appearance of the skin.

Uses

INDICATIONS & USAGE SECTION

Indications:
IMPROVE SKIN QUALITY AND REDUCE WRINKLES AND FINE LINES.
PROMOTE A YOUTHFUL APPEARANCE AND EVEN SKIN TONE.
REDUCE DARK SPOTS, PIGMENTATION, AND UNEVEN SKIN TONE.

WARNINGS

WARNINGS SECTION

For external use only

Do not use

OTC - STOP USE SECTION

On damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

Discontinue use immediately if you experience severe discomfort and seek medical attention promptly.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions for use

DOSAGE & ADMINISTRATION SECTION

Twice daily, in the morning and evening. Recommended usage amount: A pea to cherry-sized amount (about 2-3 grams) is sufficient for each use.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Water: 50%
Glycerin: 5%
Cetyl Alcohol: 2%
Caprylic/Capric Triglyceride: 5%
Butyrospermum Parkii (Shea) Butter: 3%
Cocos Nucifera (Coconut) Oil: 3%
Synthetic Beeswax: 1%
Oryza Sativa (Rice) Bran Extract: 1%
Helianthus Annuus (Sunflower) Extract: 1%
Panthenol: 1%
Benzyl Salicylate: 0.5%
Butylene Glycol: 2%
Xanthan Gum: 0.5%

Other Information

STORAGE AND HANDLING SECTION

Store in a cool, dry place, avoid direct sunlight.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83872-078THERETINOLCREAM (RETINOLCREAM) CREAM [SHENZHEN XIAOMAI MANUFACTURING CO., LTD.]1Unmatched20240402_150602cc-edd8-7a83-e063-6394a90abb3c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83872-07883872-078-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
THEOBROMA GRANDIFLORUM SEED BUTTERI711F13FXMACTIB
CERAMIDE NP4370DF050BACTIB
PALMITOYL TETRAPEPTIDE-7Q41S464P1RACTIB
SUNFLOWER OIL3W1JG795YIIACT
LAVANDULA ANGUSTIFOLIA FLOWER19AH1RAF4MACTIB
BERTHOLLETIA EXCELSA FLOWERNI60Y19CKFACTIB
EUTERPE OLERACEA WHOLEY57H6218HPACTIB
CARROT SEED OIL595AO13F11ACTIB
PUNICA GRANATUM FLOWERD9B634V4GPACTIB
GLYCERINPDC6A3C0OXIACT
TOCOPHEROLR0ZB2556P8ACTIB
ASCORBIC ACIDPQ6CK8PD0RACTIB
WATER059QF0KO0RIACT
CETYL ALCOHOL936JST6JCNIACT
BENZYL SALICYLATEWAO5MNK9TUIACT
XANTHAN GUMTTV12P4NEEIACT
RETINOLG2SH0XKK91ACTIB
HYALURONIC ACIDS270N0TRQYACTIB
MATRICARIA RECUTITA FLOWERING TOP3VNC7T6Z02ACTIB
COCONUT OILQ9L0O73W7LIACT
ORYZA SATIVA WHOLE84IVV0906ZIACT
ROSMARINUS OFFICINALIS FLOWERNR1A27F29OACTIB
SYNTHETIC BEESWAX08MNR5YE2RIACT
PANTHENOLWV9CM0O67ZIACT
BUTYLENE GLYCOL3XUS85K0RAIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
36586daa-5ffe-a1fb-e063-6294a90a93e3150602cc-edd8-7a83-e063-6394a90abb3c2025-05-30WarningsExact identifier
spl set id: 150602cc-edd8-7a83-e063-6394a90abb3c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.