FDA.reportPublic FDA data

GLYTONE Gentle Rejuvenating Lotion Broad Spectrum SPF 15

Manufacturer
Genesis Pharmaceutical, Inc.
Effective date
2018-08-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:52:28

Label at a glance#

ProductGLYTONE Gentle Rejuvenating Broad Spectrum SPF 15
Active ingredientAVOBENZONE, OCTINOXATE
Label structure8 sections

Dosage and administration

Apply Gentle Rejuvenating Lotion in the morning to cleansed face and neck 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 ...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2 %

Octinoxate 7 %

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.

Warnings

WARNINGS SECTION

For external use only

Sunburn alert:

SPL UNCLASSIFIED SECTION

This product contains an alpha hydroxy acid (AHA) that may increase skin 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.

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 Gentle Rejuvenating Lotion in the morning to cleansed face and neck 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 this risk, regularly use a sunscreen with a broad spectrum SFP of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 am - 2 pm.
    • wear long-sleeve shirts, pants, hats and sunglasses

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, GLYCOLIC ACID, CYCLOMETHICONE, BUTLOCTYL SALICYLATE, GLYCERYL STEARATE, GLYCERIN, STEAROXY DIMETHICONE, AMMONIUM HYDROXIDE, PEG-150 STEARATE, CETYL ALCOHOL, DIMETHICONOL, GLYCINE SOJA (SOYBEAN) STEROLS, PHENOXYETHANOL, XANTHAN GUM, METHYLPARABEN, POLYACRYLAMIDE, TOCOPHERYL ACETATE, DISODIUM EDTA, C13-14 ISOPARAFFIN, LAURETH-7.

PRINCIPAL DISPLAY PANEL - Gentle Rejuvenating Lotion 60 ml Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GLYTONE

Gentle

Rejuvenating

Lotion

Broad Spectrum SPF 15

REJUVENATING

14.0 Glycolic Acid Complex

60 mL / 2 FL. OZ.

GLYTONE Gentle Rejuvenating Lotion 60 ml CartonGLYTONE Gentle Rejuvenating Lotion 60 ml Carton

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64760-71564760-715-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
WATER059QF0KO0RIACT
GLYCOLIC ACID0WT12SX38SIACT
CYCLOMETHICONENMQ347994ZIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
GLYCERINPDC6A3C0OXIACT
AMMONIA5138Q19F1XIACT
PEG-150 STEARATE7BSG7DF10QIACT
CETYL ALCOHOL936JST6JCNIACT
DIMETHICONOL (250000 MW)RKI3S914RTIACT
SOY STEROLPL360EPO9JIACT
PHENOXYETHANOLHIE492ZZ3TIACT
XANTHAN GUMTTV12P4NEEIACT
METHYLPARABENA2I8C7HI9TIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
EDETATE DISODIUM7FLD91C86KIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
LAURETH-7Z95S6G8201IACT

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
adfa2516-b2c3-4475-92c3-56dfd325ee41cfa43a3a-111f-4195-9930-47c944b2a7a22018-08-28WarningsExact identifier
spl id: adfa2516-b2c3-4475-92c3-56dfd325ee41
spl set id: cfa43a3a-111f-4195-9930-47c944b2a7a2

Reported adverse events (FAERS/openFDA)#

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