LONG-LASTING OIL-FREE MOISTURIZER- avobenzone, octisalate, octocrylene and oxybenzone cream

Long-Lasting Oil-Free Moisturizer by

Drug Labeling and Warnings

Long-Lasting Oil-Free Moisturizer by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Avobenzone 2.0%
Octisalate 5.0%
Octocrylene 4.0%
Oxybenzone 3.0%

Purpose

Sunscreen

Uses

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

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

Directions

• Apply liberally 15 minutes before sun exposure.
• Children under 6 months of age: ask a doctor
• 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 SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses

Other Information

• protect the product in this container from excessive heat and direct sun

Inactive ingredients

water, carbomer, cetearyl alcohol, ceteareth-20, glycerin, c12-15 alkyl benzoate, glyceryl stearate, peg-100 stearate, diisopropyl adipate, propylene glycol, diazolidinyl urea, methylparaben, propylparaben, dimethicone, triethanolamine

Questions?

1-888-423-0139

Package/Label Principal Display Panel

TopCare Long Lasting Oil-Free Moisturizer
Broad Spectrum SPF15 Sunscreen For FACE

Hypoallergenic
Non-comedogenic
Dermatologist tested

SPF 15
*compare to Neutrogena® Oil-Free Moisture SPF 15 Ingredients
With Broad Spectrum sun protection

4 FL OZ (118mL)

DISTRIBUTED BY TOPCO ASSOCIATES LLC
7711 GROSS POINT ROAD, SKOKIE, IL 60077
©TOPCO PER1109
QUESTIONS? 1-888-423-0139
topcare@topco.com

Manufactured in Israel
82026 88 C2

Carton Label

INGREDIENTS AND APPEARANCE

LONG-LASTING OIL-FREE MOISTURIZER 
avobenzone, octisalate, octocrylene and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-360
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mL  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER 1342 (UNII: 809Y72KV36)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
GLYCERIN (UNII: PDC6A3C0OX)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-360-45	1 in 1 CARTON
1		118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/11/2012

Labeler - Topco Associates LLC (006935977)