FDA.reportPublic FDA data

GLYTONE Sunscreen Lotion Broad Spectrum SPF 40

Manufacturer
Pierre Fabre USA Inc.
Effective date
2023-01-02
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
legacy-cache
Hydrated at
2026-08-01 21:33:31

Label at a glance#

ProductGlytone Sunscreen SPF 40
Active ingredientOCTINOXATE, OCTISALATE, ZINC OXIDE
Label structure9 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

Apply liberally 15 minutes before sun exposure Reapply: •after 40 minutes of swimming or sweating •immediately after towel drying •at least every 2 hours Sun Protection Measures. 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 of 15 or higher and other sun protection measures including: •limit time in the s...

Label contents#

Full prescribing information#

Active Ingredients  

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Octisalate 2% 

Zinc Oxide 7.65%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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

  • Apply liberally 15 minutes before sun exposure
  • Reapply:

•after 40 minutes of swimming or sweating

•immediately after towel drying

•at least every 2 hours

  • Sun Protection Measures. 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 of 15 or higher and other sun protection measures including:

•limit time in the sun, especially from 10 a.m. - 2 p.m.

•wear long-sleeved shirts, pants, hats and sunglasses

  • Children under 6 months: Ask a doctor

Other Information

INFORMATION FOR PATIENTS SECTION

Protect the product in this container from excessive heat and direct sunlight.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER, ISOPROPYL MYRISTATE, OCTYLDODECYL NEOPENTANOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETEARYL ALCOHOL, POLYSORBATE 60, DEA-CETYL PHOSPHATE,  C13-14 ISOPARAFFIN, CITRIC ACID, DISODIUM EDTA, GALACTOARABINAN, HYALURONIC ACID, LAURETH-7, METHYLPARABEN, PHENOXYETHANOL, POLYACRYLAMIDE, POLYETHER-1, PROPYLPARABEN, SODIUM HYDROXIDE, TRIETHOXYCAPRYLYLSILANE.

Questions?

OTC - QUESTIONS SECTION

 1-800-GLYTONE (459-8663). You may also report adverse events to this number.

Principal Display Panel - Sunscreen Lotion Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GLYTONE

Sunscreen

Lotion

Broad Spectrum SPF 40

SUN PROTECTION

Micronized Zinc Oxide

Hyaluronic Acid

WATER RESISTANT (40 MINUTES)

FRAGRANCE-FREE – OIL-FREE

120 mL / 4 FL. OZ.

SunscreenSPF40SunscreenSPF40

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64760-716-012023-04-04C16284748780-1ba0f9c33-2b93-a910-e053-dadaa90a0b85GLYTONE Sunscreen Lotion Broad Spectrum SPF 40
64760-716-022023-04-04C16284748780-1ba0f9c33-2b93-a910-e053-dadaa90a0b85GLYTONE Sunscreen Lotion Broad Spectrum SPF 40
64760-716-012023-01-30C16284748780-1ba0f9c33-2b93-a910-e053-dadaa90a0b85GLYTONE Sunscreen Lotion Broad Spectrum SPF 40
64760-716-022023-01-30C16284748780-1ba0f9c33-2b93-a910-e053-dadaa90a0b85GLYTONE Sunscreen Lotion Broad Spectrum SPF 40
64760-716-012021-02-03C16284748780-1ba0f9c33-2b93-a910-e053-dadaa90a0b85GLYTONE Sunscreen Lotion Broad Spectrum SPF 40
64760-716-022021-02-03C16284748780-1ba0f9c33-2b93-a910-e053-dadaa90a0b85GLYTONE Sunscreen Lotion Broad Spectrum SPF 40
64760-716-012021-01-29C16284748780-1ba0f9c33-2b93-a910-e053-dadaa90a0b85GLYTONE Sunscreen Lotion Broad Spectrum SPF 40
64760-716-022021-01-29C16284748780-1ba0f9c33-2b93-a910-e053-dadaa90a0b85GLYTONE Sunscreen Lotion Broad Spectrum SPF 40

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64760-71664760-716-01, 64760-716-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYSORBATE 60CAL22UVI4MIACT
DIETHANOLAMINE CETYL PHOSPHATE4UG0316V9SIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE DISODIUM7FLD91C86KIACT
GALACTOARABINANSL4SX1O487IACT
HYALURONIC ACIDS270N0TRQYIACT
LAURETH-7Z95S6G8201IACT
METHYLPARABENA2I8C7HI9TIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
2H-TRICOSAFLUORO-5,8,11,14-TETRAKIS(TRIFLUOROMETHYL)-3,6,9,12,15-PENTAOXAOCTADECANESEF36F005EIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM HYDROXIDE55X04QC32IIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIB

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
0f5135a6-84bb-e239-e063-6294a90a6c96f29e4e23-5530-4cd1-b4b8-7cc0004a2b912024-01-19WarningsExact identifier
spl set id: f29e4e23-5530-4cd1-b4b8-7cc0004a2b91

Reported adverse events (FAERS/openFDA)#

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