Glytone Daily Body Lotion Broad Spectrum SPF 15

Manufacturer
Pierre Fabre USA Inc.
Effective date
2024-01-18
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:13:57

Label at a glance#

ProductGlytone Daily Body
Active ingredientOXYBENZONE, OCTOCRYLENE, OCTINOXATE, AVOBENZONE
Label structure8 sections

Dosage and administration

Apply Daily Body Lotion once daily or as directed by a doctor at least 15 minutes before sun exposure. At least every 2 hours apply a sunscreen with broad spectrum SPF 15 or higher for sun protection. 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 the risk, regulatory use a sunscreen with...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2%

Octinoxate 7.5%

Octocrylene 1.86%

Oxybenzone 3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn

Warnings

WARNINGS SECTION

  • For external use only.
  • Sunburn alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for one week afterwards.

Do not use

OTC - DO NOT USE SECTION

  • as a sunscreen for sunbathing.
  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

Keep out of reach of children. Do not swallow.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply Daily Body Lotion once daily or as directed by a doctor at least 15 minutes before sun exposure.
  • At least every 2 hours apply a sunscreen with broad spectrum SPF 15 or higher for sun protection.
  • 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 the risk, regulatory use a sunscreen with a broad spectrum SPF 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.

Other information

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun.
  • May stain fabrics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycolic Acid, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Sodium Hydroxide, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Cyclotetrasiloxane, PEG-40 Stearate, Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Cetearyl Glucoside, Cetyl Alcohol, Cholesterol, Dimethiconol, Disodium EDTA, Laureth-7, Methylparaben, Phenoxyethanol, Polyacrylamide, Tocopheryl Acetate, Xanthan Gum.

Principal Display Panel 355 mL / 12 FL. OZ.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GLYTONE

Daily Body Lotion

Broad Spectrum SPF 15

Glycolic Acid Complex

355 mL / 12 FL. OZ

DailyBodyLotionSPF15DailyBodyLotionSPF15

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64760-713GLYTONE DAILY BODY (AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) LOTION [PIERRE FABRE USA INC.]5Legacy NDC20240119_91baf7df-a1fa-6739-e053-2a95a90a6e31.zip

Products#

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

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64760-71364760-713-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 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
0f3b7a44-c811-03b4-e063-6294a90a53be91baf7df-a1fa-6739-e053-2a95a90a6e312024-01-18WarningsExact identifier
spl id: 0f3b7a44-c811-03b4-e063-6294a90a53be
spl set id: 91baf7df-a1fa-6739-e053-2a95a90a6e31

Reported adverse events (FAERS/openFDA)#

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