GLYTONE DAILY BODY- avobenzone, octinoxate, octocrylene, oxybenzone lotion

Glytone Daily Body by

Drug Labeling and Warnings

Glytone Daily Body 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

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

INGREDIENTS AND APPEARANCE

GLYTONE DAILY BODY 
avobenzone, octinoxate, octocrylene, oxybenzone lotion

Product 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
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 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 not final	part352	10/03/2017

Labeler - Pierre Fabre USA Inc. (117196928)

Registrant - Pierre Fabre USA Inc. (117196928)