FDA.reportPublic FDA data

SYMBA Skin Lightening

Manufacturer
Craig Doura LLC
Effective date
2017-12-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:53:32

Label at a glance#

ProductSYMBA Skin Lightening
Active ingredientHYDROQUINONE
Label structure8 sections

Indications and uses

Gradually lightens uneven and dark discoloration. Fades freckles, age, and liver spots. Moisturizes the skin. Leaves skin perfumed, soft, and smooth.

Dosage and administration

for sensitive skin, test overnight on a small section of skin inside the elbow before use apply a thin layer to skin on affected areas use sunscreen to prevent darkening from recurring use twice daily for at least 6 weeks or as directed by doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone 1.9%

Purpose

OTC - PURPOSE SECTION

Skin Lightening Agent

Uses

INDICATIONS & USAGE SECTION

Gradually lightens uneven and dark discoloration. Fades freckles, age, and liver spots. Moisturizes the skin. Leaves skin perfumed, soft, and smooth.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on irritated or broken skin
  • on children under 12 years old
  • to prevent sunburn
  • in combination with products containing Resorcinol, Phenol, or Salicylic Acid

When using this product

OTC - WHEN USING SECTION

  • mild irritation or temporary skin darkening may occur
  • avoid contact with eyes
  • avoid unnecessary sun exposure

Stop use and consult a doctor if

OTC - STOP USE SECTION

  • darkening persists
  • irritation becomes severe

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, consult a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. If swallowed, call poison control or get medical attention immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • for sensitive skin, test overnight on a small section of skin inside the elbow before use
  • apply a thin layer to skin on affected areas
  • use sunscreen to prevent darkening from recurring
  • use twice daily for at least 6 weeks or as directed by doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Glyceryl Monostearate, Propylene Glycol, Papaya Extract (Carica Papaya Fruit Extract), Mineral Oil(Paraffinum Liquidum), Cetyl Palmitate, Isopropyl Myristate, Dimethicone, Sodium Lauryl Sulphate, Allantoin, Fragrance (Parfum), Sodium Metabisulfite, Ascorbic Acid (Vitamin C), Propylparaben, Edetate Disodium, FD&C Yellow 5.

PRINCIPAL DISPLAY PANEL - 57 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SYMBA®
SKIN LIGHTENING CREAM
PAPAYA

NDC 71607-200-01

With Papaya Fruit Extract, Vitamin A, and Vitamin E

Principal Display Panel - 57 g Tube Carton
Principal Display Panel - 57 g Tube Carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROQUINONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71607-200-012020-01-31C16284748780-19d75b9d0-f367-f424-e053-dadaa90a57ceSYMBA Skin Lightening

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71607-200-01SYMBA Skin Lightening1 in 1 CARTONCREAM12
71607-200-57SYMBA Skin Lightening57 g in 1 TUBECREAM572

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71607-200SYMBA SKIN LIGHTENING (HYDROQUINONE) CREAM [CRAIG DOURA LLC]2Legacy NDC, 2 package rows20171219_dcdb95c8-217c-4369-a8b9-4fc249496d62.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71607-20071607-200-57, 71607-200-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROQUINONEXV74C1N1AEACTIB
Water059QF0KO0RIACT
GlyceryL 1-Stearate258491E1RZIACT
Propylene Glycol6DC9Q167V3IACT
PapayaKU94FIY6JBIACT
Mineral OilT5L8T28FGPIACT
Cetyl Palmitate5ZA2S6B08XIACT
Isopropyl Myristate0RE8K4LNJSIACT
Dimethicone92RU3N3Y1OIACT
Sodium lauryl Sulfate368GB5141JIACT
Allantoin344S277G0ZIACT
Sodium Metabisulfite4VON5FNS3CIACT
Ascorbic AcidPQ6CK8PD0RIACT
PropylparabenZ8IX2SC1OHIACT
Edetate Disodium7FLD91C86KIACT
FD&C Yellow NO. 5I753WB2F1MIACT

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
14c1edd5-03b9-423e-a184-179f2eba3523dcdb95c8-217c-4369-a8b9-4fc249496d622017-12-18WarningsExact identifier
spl id: 14c1edd5-03b9-423e-a184-179f2eba3523
spl set id: dcdb95c8-217c-4369-a8b9-4fc249496d62

Reported adverse events (FAERS/openFDA)#

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