Glytone Hydra Lipid UV Mineral Sunscreen

Manufacturer
Pierre Fabre USA Inc.
Effective date
2024-04-29
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:04:08

Label at a glance#

ProductGlytone Hydra Lipid UV Mineral Sunscreen SPF 40 PLUS
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure12 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 at least every 2 hours Use a water resistant sunscreen if swimming or sweating. 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 ...

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Sunscreen

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 2%

Zinc Oxide 1%

Uses

DOSAGE & ADMINISTRATION 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

Do not use on damaged or broken skin

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

Stop use and ask a doctor if rash occurs

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating.

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-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor

Other information

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Butyloctyl Salicylate, Octyldodecyl Neopentanoate, Ethylhexyl Isononanoate, Polyester-7, Glycerin, Neopentyl Glycol, Diheptanoate, Cetyl Alcohol, Glyceryl Stearate, Squalane, Phenoxyethanol, PEG-75 Stearate, Bisabolol, Hydrolyzed Sodium Hyaluronate, Pyrus Malus (Apple) Fruit Extract, C12-15 Alkyl Benzoate, Lysolecithin, Sclerotlum Gum, Dimethiconol/Octylsilsesquioxane/Silicate Crosspolymer, Allantoin, Ceteth-20, Steareth-20, Caprylyl Glycol, Triceteareth-4 Phosphate. Pullulan. Xanthan Gum, Sodium Hyaluronate, Dimethiconol/Propylsilsesquioxane/Silicate Crosspolymer
Disodium EDTA, Ethylhexylglycerin, Hexylene Glycol, Dicrateria Rotunda Oil, Ruttnera Lamellosa Oil, Lecithin, Silica, Camellia Sinensis Leaf Extract, Avena Sativa (Oat) Kernel Extract, Sodium Ascorbate, Potassium Sorbate, Tocopherol.

Questions or comments?

OTC - QUESTIONS SECTION

visit www.glytone.com or call toll-free 800-GLYTONE (459-8663)

Indications

INDICATIONS & USAGE SECTION

Apply generously 15 minutes before sun exposure

etc

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, call a Poison Control Center right away.

Do not use

OTC - DO NOT USE SECTION

On broken skin

Principal Display Panel - 50 mL Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GLYTONE

Hyda Lipid UV

Mineral Sunscreen

Broad spectrum SPF 40+

Sun Protection

Hyaluronic Acid

Squalane

Titanium Dioxide

Zinc Oxide

FRAGRANCE-FREE

50 mL / 1.7 FL. OZ.

Glytone Mineral SunscreenGlytone Mineral Sunscreen

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64760-720GLYTONE HYDRA LIPID UV MINERAL SUNSCREEN SPF 40 PLUS (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [PIERRE FABRE USA INC.]5Legacy NDC20240430_9ffa08ea-c450-80b7-e053-2a95a90a4bd6.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64760-72064760-720-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

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
174052ca-412d-8920-e063-6294a90a6af69ffa08ea-c450-80b7-e053-2a95a90a4bd62024-04-29WarningsExact identifier
spl id: 174052ca-412d-8920-e063-6294a90a6af6
spl set id: 9ffa08ea-c450-80b7-e053-2a95a90a4bd6

Reported adverse events (FAERS/openFDA)#

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