GLYTONE HYDRA LIPID UV MINERAL SUNSCREEN SPF 40 PLUS- zinc oxide, titanium dioxide lotion

Glytone Hydra Lipid UV Mineral Sunscreen by

Drug Labeling and Warnings

Glytone Hydra Lipid UV Mineral Sunscreen 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

Purpose

Sunscreen

Active ingredients

Titanium Dioxide 2%

Zinc Oxide 1%

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 eyes with water to remove.

Stop use and ask a doctor if rash occurs

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

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply at least every 2 hours
• 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 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-sleeve shirts, pants, hats, and sunglasses
• Children under 6 months: Ask a doctor

Other information

• Protect this product from excessive heat and direct sun.

Inactive ingredients

Water, Butyloctyl Salicylate, Octyldodecyl Neopentanoate, Ethylhexyl Isononanoate, Polyester-7, Glycerin, Neopentyl Glycol, Diheptanoate, Cetyl Alcohol, Glyceryl Stearate, Squalane, Phenoxyethanol, PEG-75 Stearate, Bisabolol, Hydrolyzed Sodium Hyaluronate, Pyrus Malus (Apple) Fruit Extract, C12-15 Alkyl Benzoate, Lysolecithin, Sclerotlum Gum, Dimethiconol/Octylsilsesquioxane/Silicate Crosspolymer, Allantoin, Ceteth-20, Steareth-20, Caprylyl Glycol, Triceteareth-4 Phosphate. Pullulan. Xanthan Gum, Sodium Hyaluronate, Dimethiconol/Propylsilsesquioxane/Silicate Crosspolymer
Disodium EDTA, Ethylhexylglycerin, Hexylene Glycol, Dicrateria Rotunda Oil, Ruttnera Lamellosa Oil, Lecithin, Silica, Camellia Sinensis Leaf Extract, Avena Sativa (Oat) Kernel Extract, Sodium Ascorbate, Potassium Sorbate, Tocopherol.

Questions or comments?

visit www.glytone.com or call toll-free 800-GLYTONE (459-8663)

Indications

Apply generously 15 minutes before sun exposure

etc

Keep out of reach of children.

If swallowed, call a Poison Control Center right away.

Do not use

On broken skin

Principal Display Panel - 50 mL Carton

GLYTONE

Hyda Lipid UV

Mineral Sunscreen

Broad spectrum SPF 40+

Sun Protection

Hyaluronic Acid

Squalane

Titanium Dioxide

Zinc Oxide

FRAGRANCE-FREE

50 mL / 1.7 FL. OZ.

INGREDIENTS AND APPEARANCE

GLYTONE HYDRA LIPID UV MINERAL SUNSCREEN  SPF 40 PLUS
zinc oxide, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64760-720
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2 mg  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-75 STEARATE (UNII: OT38R0N74H)
.BETA.-BISABOLOL (UNII: LP618AV2EA)
APPLE FRUIT OIL (UNII: 9NT987I3A8)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
OAT KERNEL OIL (UNII: 3UVP41R77R)
SODIUM ASCORBATE (UNII: S033EH8359)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ALPHA-TOCOPHEROL, L- (UNII: 82190DH9F2)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DICRATERIA ROTUNDA OIL (UNII: Z0DWU9R4GM)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)
POLYESTER-7 (UNII: 0841698D2F)
C12-15 ALKYL ETHYLHEXANOATE (UNII: GQJ580CH83)
LOCUST BEAN GUM (UNII: V4716MY704)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
SQUALANE (UNII: GW89575KF9)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
RUTTNERA LAMELLOSA OIL (UNII: 5XZ38R4SUT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64760-720-01	1 in 1 CARTON	07/02/2020	03/31/2026
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	07/02/2020	03/31/2026

Labeler - Pierre Fabre USA Inc. (117196928)

Registrant - Pierre Fabre USA Inc. (117196928)