Label: GLYTONE DAILY BODY- avobenzone, octinoxate, octocrylene, oxybenzone lotion
- NDC Code(s): 64760-713-01
- Packager: Pierre Fabre USA Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 18, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
- Use
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Warnings
- For external use only.
- Sunburn alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for one week afterwards.
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Directions
- Apply Daily Body Lotion once daily or as directed by a doctor at least 15 minutes before sun exposure.
- At least every 2 hours apply 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 the risk, regulatory use a sunscreen with a broad spectrum SPF 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
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Inactive ingredients
Water, Glycolic Acid, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Sodium Hydroxide, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Cyclotetrasiloxane, PEG-40 Stearate, Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Cetearyl Glucoside, Cetyl Alcohol, Cholesterol, Dimethiconol, Disodium EDTA, Laureth-7, Methylparaben, Phenoxyethanol, Polyacrylamide, Tocopheryl Acetate, Xanthan Gum.
- Principal Display Panel 355 mL / 12 FL. OZ.
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INGREDIENTS AND APPEARANCE
GLYTONE DAILY BODY
avobenzone, octinoxate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64760-713 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 3 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1.86 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947) CYCLOMETHICONE 4 (UNII: CZ227117JE) PEG-40 STEARATE (UNII: ECU18C66Q7) SHEA BUTTER (UNII: K49155WL9Y) LAURETH-7 (UNII: Z95S6G8201) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) CHOLESTEROL (UNII: 97C5T2UQ7J) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DIMETHICONOL (100000 CST) (UNII: OSA9UP217S) METHYLPARABEN (UNII: A2I8C7HI9T) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) CETYL ALCOHOL (UNII: 936JST6JCN) SODIUM HYDROXIDE (UNII: 55X04QC32I) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCOLIC ACID (UNII: 0WT12SX38S) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64760-713-01 355 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 10/03/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 10/03/2017 07/26/2025 Labeler - Pierre Fabre USA Inc. (117196928) Registrant - Pierre Fabre USA Inc. (117196928)
