GLYTONE SUNSCREEN SPF 40- octinoxate, octisalate, zinc oxide lotion

Glytone Sunscreen SPF 40 by

Drug Labeling and Warnings

Glytone Sunscreen SPF 40 by is a Otc medication manufactured, distributed, or labeled by Genesis Pharmaceutical, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

INGREDIENTS AND APPEARANCE

GLYTONE SUNSCREEN SPF 40 
octinoxate, octisalate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64760-716
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	20 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	76.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64760-716-01	1 in 1 CARTON	03/06/2018
1		120 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 64760-716-02	3 mL in 1 PACKET; Type 0: Not a Combination Product	03/06/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/06/2018

Labeler - Pierre Fabre USA Inc. (117196928)

Registrant - Pierre Fabre USA Inc. (117196928)