Teatrical ® Pro-Aclarant Day Cream

Manufacturer
Genomma Lab USA
Effective date
2020-04-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:07:25

Label at a glance#

ProductTeatrical Pro-Aclarant Day
Active ingredientAvobenzone, Octinoxate, Octocrylene
Label structure10 sections

Dosage and administration

apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other skin protection measures including: limit time in the sun, especially from 10am ...

Storage and handling

protect from excessive heat and direct sun. may stain some fabrics. keep this carton for future reference.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Avobenzone 3.0%Sunscreen
Octinoxate 7.0%Sunscreen
Octocrylene 5.0%Sunscreen

Use

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use

SPL UNCLASSIFIED SECTION

  • apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating.

Sun Protection Measures

SPL UNCLASSIFIED SECTION

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other skin protection measures including:

  • limit time in the sun, especially from 10am to 2pm
  • wear long-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • protect from excessive heat and direct sun.
  • may stain some fabrics.
  • keep this carton for future reference.

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, CETYL ALCOHOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, BUTYLENE GLYCOL, DIMETHICONE, GLYCERYL STEARATE, PEG-100 STEARATE, ISOPROPYL PALMITATE, POLYACRYLATE-13, POLYISOBUTENE, POLYSORBATE 20, BUTYROSPERMUM PARKII BUTTER, PANTHENOL, STEARETH-20, SODIUM HYALURONATE, NIACINAMIDE, TETRAHEXYLDECYL ASCORBATE, CAMELLIA SINENSIS LEAF EXTRACT, PHENOXYETHANOL, BENZOIC ACID, ETHYLHEXYLGLYCERIN.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-877-994-3666

SPL UNCLASSIFIED SECTION

Distributed by:
Genomma Lab USA Inc., Houston,
TX 77027

PRINCIPAL DISPLAY PANEL - 48 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WITH SUNSCREEN

teatrical®

PRO-ACLARANT
SKIN BRIGHTENING

DAY
CREAM

15
SPF BROAD SPECTRUM

VITAMIN B3 &
WHITE TEA EXTRACT

Helps unify skin tone
Prevents sun damage on skin

NET WT 1.7 OZ (48 g)

PRINCIPAL DISPLAY PANEL - 48 g Tube Carton
PRINCIPAL DISPLAY PANEL - 48 g Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50066-071-012022-01-28C16284748780-1d6a99b39-be63-a426-e053-dadaa90af4c2Teatrical ® Pro-Aclarant Day Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-071-01Teatrical Pro-Aclarant Day1 in 1 CARTONCREAM11
50066-071-01Teatrical Pro-Aclarant Day48 g in 1 TUBECREAM481

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-071TEATRICAL PRO-ACLARANT DAY (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [GENOMMA LAB USA]1Legacy NDC, 2 package rows20200423_4f7a2e13-cd08-4b2f-b6ec-1305897f7b83.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-07150066-071-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML · Source PDF

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
f3a39fbc-2894-4747-b4a1-32920e56ce6f4f7a2e13-cd08-4b2f-b6ec-1305897f7b832020-04-22WarningsExact identifier
spl id: f3a39fbc-2894-4747-b4a1-32920e56ce6f
spl set id: 4f7a2e13-cd08-4b2f-b6ec-1305897f7b83

Reported adverse events (FAERS/openFDA)#

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