GLYTONE GENTLE REJUVENATING BROAD SPECTRUM SPF 15- avobenzone, octinoxate 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 Gentle Rejuvenating Lotion Broad Spectrum SPF 15

Drug Facts

Active ingredients

Avobenzone 2 %

Octinoxate 7 %

Purpose

Sunscreen

Use

Helps prevent sunburn.

Warnings

For external use only

Sunburn alert:

This product contains an alpha hydroxy acid (AHA) that may increase skin 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.

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

Directions

Apply Gentle Rejuvenating Lotion in the morning to cleansed face and neck 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 this risk, regularly use a sunscreen with a broad spectrum SFP 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

Other information

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

Inactive ingredients

WATER, GLYCOLIC ACID, CYCLOMETHICONE, BUTLOCTYL SALICYLATE, GLYCERYL STEARATE, GLYCERIN, STEAROXY DIMETHICONE, AMMONIUM HYDROXIDE, PEG-150 STEARATE, CETYL ALCOHOL, DIMETHICONOL, GLYCINE SOJA (SOYBEAN) STEROLS, PHENOXYETHANOL, XANTHAN GUM, METHYLPARABEN, POLYACRYLAMIDE, TOCOPHERYL ACETATE, DISODIUM EDTA, C13-14 ISOPARAFFIN, LAURETH-7.

PRINCIPAL DISPLAY PANEL - Gentle Rejuvenating Lotion 60 ml Carton

GLYTONE

Gentle

Rejuvenating

Lotion

Broad Spectrum SPF 15

REJUVENATING

14.0 Glycolic Acid Complex

60 mL / 2 FL. OZ.

GLYTONE Gentle Rejuvenating Lotion 60 ml Carton

GLYTONE GENTLE REJUVENATING BROAD SPECTRUM SPF 15
avobenzone, octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64760-715
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	70 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCOLIC ACID (UNII: 0WT12SX38S)
CYCLOMETHICONE (UNII: NMQ347994Z)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
AMMONIA (UNII: 5138Q19F1X)
PEG-150 STEARATE (UNII: 7BSG7DF10Q)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONOL (250000 MW) (UNII: RKI3S914RT)
SOY STEROL (UNII: PL360EPO9J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64760-715-01	1 in 1 CARTON	03/13/2018	11/30/2020
1		60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	05/20/2010	11/30/2020

Labeler - Genesis Pharmaceutical, Inc. (117196928)

Revised: 8/2018

Document Id: adfa2516-b2c3-4475-92c3-56dfd325ee41

Set id: cfa43a3a-111f-4195-9930-47c944b2a7a2

Version: 1

Effective Time: 20180828

Genesis Pharmaceutical, Inc.