GLYTONE SUNCARE BLOCK SUNSCREEN   - octinoxate, octisalate and zinc oxide lotion 
Glytone

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Glytone suncare block sunscreen

Inactive Ingredients Water USP, Isopropyl Myristate, Octyldoceyl Neopentanoate, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Polysorbate 60, Diethanolamine Cetyl Phosphate, Hyaluronic Acid, Polyether-1, Galactoarabinan, Polyacrylamide, C13-14 isoparaffin, Laureth-7, Triethoxycaprylylsilane, Sodium Hydroxide, Citric Acid, Phenoxyethanol, Methylparaben, Propylparaben, Disodium EDTA

Active Ingredients                                       Purpose

Octinoxate 7.5%                                             Sunscreen

Octisalate 2%                                                  Sunscreen

Zinc Oxide 7.5%                                             Sunscreen

Uses

Helps prevent sunburn caused by UVA/UVB exposure

Provides high UVB protection

Directions

Apply at least every 2 hours and after towel drying, swimming or perspiring

Children under 6 months of age: ask a doctor

Reapply to dry skin as needed or after towel drying, swimming or sweating

Warnings

For external use only

UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen

Stop use and ask a doctor if skin rash occurs

Keep out of reach of children

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

Glytone suncare block sunscreen lotion SPF 40

UVA/UVB

PAPA-FREE

FRAGRANCE-FREE

NON-IRRITATING

OIL-FREE

NON COMEDOGENIC

MINERAL BASED (WITH MICRONIZED ZINC OXIDE)

120 ML/4 FL.OZ

GLYTONE SUNCARE BLOCK SUNSCREEN   octinoxate, octisalate, xinc oxide   lotion

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 64760-215 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength octinoxate (octinoxate) octinoxate 9 mL  in 120 mL octisalate (octisalate) octisalate 2.4 mL  in 120 mL zinc oxide (zinc oxide) zinc oxide 9 mL  in 120 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 64760-215-01 1 TUBE In 1 CARTON contains a TUBE 1 120  mL In 1 TUBE This package is contained within the CARTON (64760-215-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/25/2010

Labeler - Glytone (117196928)

Revised: 06/2010Glytone