Glytone Age Defense UV Mineral Sunscreen Serum Broad Spectrum SPF 50 PLUS

Glytone Age Defense UV Mineral Sunscreen Serum Broad Spectrum SPF 50 PLUS by

Drug Labeling and Warnings

Glytone Age Defense UV Mineral Sunscreen Serum Broad Spectrum SPF 50 PLUS by is a Otc medication manufactured, distributed, or labeled by Pierre Fabre USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GLYTONE AGE DEFENSE UV MINERAL SUNSCREEN SERUM BROAD SPECTRUM SPF 50 PLUS- zinc oxide lotion 
Pierre Fabre USA Inc.

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Glytone Age Defense UV Mineral Sunscreen Serum Broad Spectrum SPF 50 PLUS

Drug Facts

Purpose

Sunscreen

Active Ingredient

Zinc Oxide 12%

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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

limiting time in the sun, especially from 10 a.m.-2 p.m.
wearing long-sleeved shirts, pants, hats and sunglasses
Children under 6 months of age: ask a doctor.

Other Information

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

Inactive Ingredients

ALLANTOIN, ANOGEISSUS LEIOCARPA BARK EXTRACT, BISABOLOL, BUTYLOCTYL SALICYLATE, C12-15 ALKYL BENZOATE, CAPRYLYL GLYCOL, CAPRYLYL METHICONE, DIMETHICONE, DIMETHICONOL/PROPYLSILSESQUIOXANE/
SILICATE CROSSPOLYMER, ETHYLHEXYLGLYCERIN, HEXYLENE GLYCOL, HYDROLYZED SODIUM HYALURONATE,
ISODODECANE, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, LAURYL PEG-8 DIMETHICONE, NIACINAMIDE, OCTYLDODECYL NEOPENTANOATE, PEG-10, PHENOXYETHANOL, POLYMETHYLSILSESQUIOXANE, PROPANEDIOL, SODIUM CHLORIDE, SODIUM HYALURONATE, SODIUM HYDROXIDE, TETRASODIUM GLUTAMATE DIACETATE, TOCOPHEROL, TOCOPHERYL ACETATE, TRILAURETH-4 PHOSPHATE, WATER

Questions?

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

Principal Display Panel - 50 mL Carton

GLYTONE

Age Defense UV

Mineral Sunscreen Serum

Broad Spectrum SPF 50+

Sun Protection

Zinc Oxide

Ellagic Acid

Niacinamide

Vitamin E

Water-Resistant (40 min)

Fragrance-Free

50 mL / 1.7 FL. OZ.

GLYTONE AGE DEFENSE UV MINERAL SUNSCREEN SERUM BROAD SPECTRUM SPF 50 PLUS 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64760-730
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	120 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANOGEISSUS LEIOCARPUS BARK (UNII: U5TP1X38RH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
WATER (UNII: 059QF0KO0R)
TOCOPHEROL (UNII: R0ZB2556P8)
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISODODECANE (UNII: A8289P68Y2)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
NIACINAMIDE (UNII: 25X51I8RD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64760-730-01	1 in 1 CARTON	05/17/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/17/2021	07/01/2024

Labeler - Pierre Fabre USA Inc. (117196928)

Registrant - Pierre Fabre USA Inc. (117196928)

Revised: 1/2024

Document Id: 0f3b4e82-4f10-eaaf-e063-6294a90a7ef4

34390-5

Set id: c288692d-fd12-bb2b-e053-2a95a90a7af6

Version: 4

Effective Time: 20240118