NEO CLASSIC HOMME SPORTS 31700111- ensulizole, octinoxate and zinc oxide cream cream

NEO CLASSIC HOMME SPORTS by

Drug Labeling and Warnings

NEO CLASSIC HOMME SPORTS by is a Otc medication manufactured, distributed, or labeled by THEFACESHOP CO., LTD., THEFACESHOP NORTH AMERICA, INC., THEFACESHOP Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Ensulizole 3.7 %

Octinoxate 5.0 %

Zinc Oxide 9.0 %

Purpose

Sunscreen

Sunscreen

Sunscreen

Warnings

For external use only.

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.

Keep out of reach of children.

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

Directions

Apply generously and evenly 15 minutes before sun exposure.
Children under 6 months of age: Ask a doctor
Apply an adequate amount on the face after cleansing and toning.
Reapply at least every 2 hours.
Skin Cancer/Skin Aging Alert: Spending time in the sun
increases your risk of skin cancer and early skin aging. This
product has been shown only to help prevent sunburn, not
skin cancer or early skin aging.
Use a water-resistant sunscreen if swimming or sweating

Apply an adequate amount on the face after cleansing and toning

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and
direct sun.
May stain or damage some fabrics or surfaces.

Inactive Ingredients

WATERCYCLOPENTASILOXANEPEG-10 DIMETHICONE
DIMETHICONE/METHICONE COPOLYMERBUTYLENE GLYCOL
TITANIUM DIOXIDEHEXYL LAURATEMETHICONEALUMINA
DIMETHICONE CROSSPOLYMERTRIETHANOLAMINESILICA
DIPROPYLENE GLYCOLCETYL ETHYLHEXANOATE
DISTEARDIMONIUM HECTORITESORBITAN SESQUIOLEATE
ACRYLATES/DIMETHICONE COPOLYMERZINC STEARATE
METHYLPARABENPROPYLPARABENDISTEARYLDIMONIUM
CHLORIDETHYLPARABENDISODIUM EDTAONSEN-SUI
HELIANTHUS ANNUUS (SUNFLOWER)
SEED EXTRACTMORUS ALBA BARK
EXTRACTFRAGRANCE

QUESTIONS

Questions or comments? Call 1 (866) 638-8417

Distributed by:

THEFACESHOP NORTH AMERICA, INC.
Santa Fe Springs, CA 90670

PRINCIPAL DISPLAY PANEL

SPORTS SUNSCREEN CREAM SPF50

This outdoor-use sunscreen is suitable
for men who enjoy sports and travelling
due to its powerful sunscreening(UVA/
UVB) effects.

INGREDIENTS AND APPEARANCE

NEO CLASSIC HOMME SPORTS  31700111
ensulizole, octinoxate and zinc oxide cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51523-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	1.7 g  in 45 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.3 g  in 45 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.1 g  in 45 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51523-123-02	1 in 1 CARTON	11/20/2014
1		45 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/20/2014

Labeler - THEFACESHOP CO., LTD. (688329416)

Registrant - THEFACESHOP NORTH AMERICA, INC. (620459193)

Establishment
Name	Address	ID/FEI	Business Operations
THEFACESHOP Co., Ltd.		688329416	label(51523-123)