FDA.reportPublic FDA data

Tone Control Morning Cream SPF 15

Manufacturer
Bentley Laboratories, LLC | Geologie
Effective date
2024-12-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:49:16

Label at a glance#

ProductTone Control Morning Cream SPF 15
Active ingredientOCTOCRYLENE, OCTISALATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

DRUG FACTS

Active Ingredients

Octocrylene 5%

Octisalate 2%

OTC - PURPOSE SECTION

Purpose .... Sunscreem

INDICATIONS & USAGE SECTION

Uses: Helps prevent sunburn.

WARNINGS SECTION

Warnings •Skin Cancer/Skin Aging Alert: Spending too much time in the sun increases your risk of
skin cancer and early skin aging. This product has been shown to only help prevent sunburn,
not skin cancer or early skin aging. • For external use only. • Do not use on damaged or broken
skin. • When using this product, keep out of eyes. Rinse with water to remove. • Stop use and
ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions• Apply generously 15 minutes before sun exposure. • Use in the morning.
• Reapply every 2 hours. • Use a water resistant sunscreen if swimming or sweating. • Rub
cream gently into your face and neck, avoiding the eyes.

OTHER SAFETY INFORMATION

Other information • Protect the product in this container from excessive heat and direct sun.

INACTIVE INGREDIENT SECTION

Inactive Ingredients  Aloe Barbadensis Leaf Juice, Water, Butyloctyl Salicylate, Cetear-
yl Olivate, Sorbitan Olivate, Glyceryl Stearate, Potassium Azeloyl Diglycinate, Glycerin, Niacina-
mide, Polyglyceryl-10 Laurate, Sodium Hyaluronate, Silica, Caffeine, Phenoxyethanol, Caprylyl
Glycol, Dimethicone, Sodium Stearoyl Glutamate, Hydroxyethyl Acrylate/Sodium
Acryloyldimethyl Taurate Copolymer, Ethyl Ferulate, Ethylhexylglycerin, Arnica Montana Flower
Extract

Product Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tone Control Morning Cream SPF 15
SPF 15

Distributed by Geologie
2578 Broadway #A212
New York, NY 10025

20 ml .67 fl oz

20 mL Label

173-20 pkg173-20 pkg

173-20 Card173-20 Card

60 mL Label

173-60 Card173-60 Card

173-60 PKG173-60 PKG

res

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54111-173-20Tone Control Morning Cream SPF 1520 mL in 1 TUBECREAM203
54111-173-60Tone Control Morning Cream SPF 1560 mL in 1 TUBECREAM603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54111-173TONE CONTROL MORNING CREAM SPF 15 (OCTOCRYLENE AND OCTISALATE CREAM) CREAM [BENTLEY LABORATORIES, LLC]3Current NDC, 2 package rows20241228_b4e3cd1c-ae42-4995-a314-96d24d328e41.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54111-17354111-173-20, 54111-173-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CETEARYL OLIVATE58B69Q84JOIACT
SORBITAN OLIVATEMDL271E3GRIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
POTASSIUM AZELOYL DIGLYCINATEN02RVN6NYPIACT
GLYCERINPDC6A3C0OXIACT
NIACINAMIDE25X51I8RD4IACT
POLYGLYCERYL-10 LAURATEMPJ2Q8WI8GIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CAFFEINE3G6A5W338EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
Caprylyl Glycol00YIU5438UIACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
ETHYL FERULATE5B8915UELWIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT

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
Tone Control Morning Cream SPF 15OCTOCRYLENE AND OCTISALATE CREAMBentley Laboratories, LLCb4e3cd1c-ae42-4995-a314-96d24d328e412024-12-27WarningsExact identifier
ndc (package): 54111-173-60
ndc (package): 54111-173-20
ndc (product): 54111-173
ndc11 (package): 54111017360
ndc11 (package): 54111017320
spl id: 709441eb-04f8-401a-aa05-86aa457261f9
spl set id: b4e3cd1c-ae42-4995-a314-96d24d328e41

Reported adverse events (FAERS/openFDA)#

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