GLYTONE DAILY BODY- avobenzone, octinoxate, octocrylene, oxybenzone lotion 
Pierre Fabre USA Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Glytone Daily Body Lotion Broad Spectrum SPF 15

Drug Facts

Active Ingredients

Avobenzone 2%

Octinoxate 7.5%

Octocrylene 1.86%

Oxybenzone 3%

Purpose

Sunscreen

Use

  • Helps prevent sunburn

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.

Do not use

  • as a sunscreen for sunbathing.
  • 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. Do not swallow.

If swallowed, get medical help or contact a Poison Control center right away.

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

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

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.

GLYTONE

Daily Body Lotion

Broad Spectrum SPF 15

Glycolic Acid Complex

355 mL / 12 FL. OZ

DailyBodyLotionSPF15

GLYTONE DAILY BODY 
avobenzone, octinoxate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-713
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.86 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64760-713-01355 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/03/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/03/2017
Labeler - Pierre Fabre USA Inc. (117196928)
Registrant - Pierre Fabre USA Inc. (117196928)

Revised: 1/2023
 
Pierre Fabre USA Inc.