GLYTONE BODY- octinoxate, oxybenzone, avobenzene, octocrylene lotion 
Genesis Pharmaceutical, 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 Body



Sunscreen Active Ingredients

Octinoxate 7.50%

Oxybenzone 3.00%

Avobenzone 2.00%

Octocrylene 1.86%




Purpose

Sunscreen



Keep out of reach of children.



Uses

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early aging caused by the sun

Skin exfoliant

Skin moisturizer



Warnings

Do not use 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

For external use only

Keep out of reach of children

Do  not swallow. If swallowed, get medical help or contact Poison Control right away

Children under 6 months: ask a doctor before use.



Directions

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reapply at least every 2 hours

Sun Protection Measures.

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 am- 2 pm, wear long sleeve shirts, pants, hats and sunglasses.


Ingredients that do not prevent Sunburn (Inactive Ingredients):

Water (aqua), Glycolic Acid, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Sodium Hydroxide, Glycerin, PEG-100 Stearate, Glceryl Stearate, Cetearyl Alcohol, Cyclotetrasiloxane, PEB-150 Stearate, Cetyl Alcohol, Dimethiconol, Cholesterol, Butyrosperum Parkii (Shea) Butter, Polyacrylamide, Phenoxyethanol, Cetearyl Glucoside, C13-14 Isoparaffin, Methylparaben, Xanthan Gum, Disodium ETA, Tocopheryl Acetate, Laureth-7


label


Glytone Body

retexturize body lotion

broad spectrum

sunscreen SPF 15

glycolic complex

12 fl. oz/355 ml.

Pierre Fabre

Distributed by: Genesis Pharmaceutical, Inc.

Parsippany, NJ 07054

Made in USA

1-800-459-8663

www.glytone-usa.com

GLYTONE BODY 
octinoxate, oxybenzone, avobenzene, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-408
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE26.63 g  in 355 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE10.65 g  in 355 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE7.1 g  in 355 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6.6 g  in 355 mL
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LAURETH-7 (UNII: Z95S6G8201)  
WATER (UNII: 059QF0KO0R)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CYCLOMETHICONE 4 (UNII: CZ227117JE)  
PEG-150 STEARATE (UNII: 7BSG7DF10Q)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIMETHICONOL (250000 MW) (UNII: RKI3S914RT)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
SHEA BUTTER (UNII: K49155WL9Y)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64760-408-02355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/12/201212/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/12/201212/31/2019
Labeler - Genesis Pharmaceutical, Inc. (117196928)

Revised: 4/2023
 
Genesis Pharmaceutical, Inc.