GLYTONE TRIPLE DEFENSE BRIGHTENING COMPLEX WITH SUNSCREEN BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene cream

GLYTONE Triple Defense Brightening Complex with Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

GLYTONE Triple Defense Brightening Complex with Sunscreen Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Pierre Fabre USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 10%

Purpose

Sunscreen

Use

• Helps prevent sunburn

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 in the morning to cleansed face and neck at least 15 minutes before sun exposure

• At least every 2 hours reapply 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          broad spectrum SPF value 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

Other information

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

Inactive ingredients

WATER, METHYL METHACRYLATE CROSSPOLYMER, ARACHIDYL ALCOHOL, UNDECYLENOYL PHENYLALANINE, DIISOPROPYL SEBACATE, PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE, NIACINAMIDE, BEHENYL ALCOHOL, C12-15 AKLYL BENZOATE, DIISOPROPYL ADIPATE, PHENOXYETHANOL, ALGAE EXTRACT, ANHYDROXYLITOL, ARACHIDYL GLUCOSIDE, BUTYLENE GLYCOL, CHONDRUS CRISPUS EXTRACT, COPPER GLUCONATE, ETHYLHEXYLGLYCERIN, LITHOTHAMNION CALCAREUM EXTRACT, MAGNESIUM ASPARTATE, POLYACRYLATE CROSSPOLYMER-6, TOCOPHERYL ACETATE, UNDARIA PINNATIFIDA EXTRACT, XYLITOL XYLITYLGLUCOSIDE, ZINC GLUCONATE

Principal Display Panel 50 mL Carton

GLYTONE

Triple Defense

Brightening

Complex

with Sunscreen

Broad Spectrum

SPF 30

50 mL / 1.7 FL. OZ.

INGREDIENTS AND APPEARANCE

GLYTONE TRIPLE DEFENSE BRIGHTENING COMPLEX WITH SUNSCREEN BROAD SPECTRUM SPF 30 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64760-717
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
UNDECYLENOYL PHENYLALANINE (UNII: 271P08C6OD)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
NIACINAMIDE (UNII: 25X51I8RD4)
DOCOSANOL (UNII: 9G1OE216XY)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
WATER (UNII: 059QF0KO0R)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LAMINARIA JAPONICA (UNII: WE98HW412B)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
COPPER GLUCONATE (UNII: RV823G6G67)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)
MAGNESIUM ASPARTATE (UNII: R17X820ROL)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S)
XYLITOL (UNII: VCQ006KQ1E)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64760-717-01	1 in 1 CARTON	02/20/2017	04/24/2021
1		50 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/20/2017	04/24/2021

Labeler - Pierre Fabre USA Inc. (117196928)

Registrant - Pierre Fabre USA Inc. (117196928)