Label: GLYTONE HYDRA LIPID UV MINERAL SUNSCREEN SPF 40 PLUS- zinc oxide, titanium dioxide lotion
- NDC Code(s): 64760-720-01
- Packager: Pierre Fabre USA Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated April 29, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Active ingredients
- Uses
- Warnings
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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
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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?
- Indications
- Keep out of reach of children.
- Do not use
- Principal Display Panel - 50 mL Carton
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INGREDIENTS AND APPEARANCE
GLYTONE HYDRA LIPID UV MINERAL SUNSCREEN SPF 40 PLUS
zinc oxide, titanium dioxide lotionProduct 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)