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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)
Available from:
Pierre Fabre USA Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen - Helps prevent sunburn
Authorization status:
OTC monograph not final
Authorization number:
64760-713-01

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

GLYTONE DAILY BODY

avobenzone, octinoxate, octocrylene, oxybenzone lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 476 0 -713

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y)

OXYBENZONE

3 g in 10 0 mL

O CTO CRYLENE (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM)

OCTOCRYLENE

1.8 6 g in 10 0 mL

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

7.5 g in 10 0 mL

AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

AVOBENZONE

2 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

GLYCERYL STEARATE/PEG-10 0 STEARATE (UNII: RD25J5V9 47)

CYCLO METHICO NE 4 (UNII: CZ227117JE)

PEG-4 0 STEARATE (UNII: ECU18 C6 6 Q7)

SHEA BUTTER (UNII: K49 155WL9 Y)

LAURETH-7 (UNII: Z9 5S6 G8 20 1)

C13 -14 ISO PARAFFIN (UNII: E4F12ROE70 )

CETEARYL GLUCO SIDE (UNII: 0 9 FUA47KNA)

CHO LESTERO L (UNII: 9 7C5T2UQ7J)

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

DIMETHICO NO L ( 10 0 0 0 0 CST) (UNII: OSA9 UP217S)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

WATER (UNII: 0 59 QF0 KO0 R)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

GLYCERIN (UNII: PDC6 A3C0 OX)

GLYCERYL STEARATE SE (UNII: FCZ5MH78 5I)

PO LYACRYLAMIDE ( 10 0 0 0 MW) (UNII: E2KR9 C9 V2I)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

GLYCO LIC ACID (UNII: 0 WT12SX38 S)

ALKYL ( C12 -15) BENZO ATE (UNII: A9 EJ3J6 1HQ)

CYCLO METHICO NE 5 (UNII: 0 THT5PCI0 R)

XANTHAN GUM (UNII: TTV12P4NEE)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 476 0 -713-

355 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

10 /0 3/20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

10 /0 3/20 17

Pierre Fabre USA Inc.

Labeler -

Pierre Fabre USA Inc. (117196928)

Registrant -

Pierre Fabre USA Inc. (117196928)

Revised: 12/2019

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