GLYTONE SUNSCREEN SPF 40- octinoxate, octisalate, zinc oxide lotion 
Pierre Fabre USA Inc.

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GLYTONE Sunscreen Lotion Broad Spectrum SPF 40

Drug Facts

Active Ingredients  

Octinoxate 7.5%

Octisalate 2% 

Zinc Oxide 7.65%

Purpose

Sunscreen

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

Warnings

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.

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

Directions

  • 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

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

Inactive Ingredients

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?

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

Principal Display Panel - Sunscreen Lotion Carton

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.

SunscreenSPF40

GLYTONE SUNSCREEN SPF 40 
octinoxate, octisalate, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-716
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE20 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE76.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GALACTOARABINAN (UNII: SL4SX1O487)  
HYALURONIC ACID (UNII: S270N0TRQY)  
LAURETH-7 (UNII: Z95S6G8201)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
2H-TRICOSAFLUORO-5,8,11,14-TETRAKIS(TRIFLUOROMETHYL)-3,6,9,12,15-PENTAOXAOCTADECANE (UNII: SEF36F005E)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64760-716-011 in 1 CARTON03/06/2018
1120 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:64760-716-023 mL in 1 PACKET; Type 0: Not a Combination Product03/06/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/06/201812/04/2021
Labeler - Pierre Fabre USA Inc. (117196928)
Registrant - Pierre Fabre USA Inc. (117196928)

Revised: 1/2024
 
Pierre Fabre USA Inc.