GLYTONE GENTLE REJUVENATING BROAD SPECTRUM SPF 15- avobenzone, octinoxate lotion

GLYTONE Gentle Rejuvenating Broad Spectrum SPF 15 by

Drug Labeling and Warnings

GLYTONE Gentle Rejuvenating Broad Spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by Genesis Pharmaceutical, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	05/20/2010	11/30/2020

Labeler - Genesis Pharmaceutical, Inc. (117196928)