ENVIRONMENTAL DEFENSE SUNSCREEN SPF 50 - octinoxate, oxybenzone, octisalate, zinc oxide and octocrylene cream
Skinmedica 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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SUN PROTECTION

Environmental Defense

Sunscreen™ SPF 50+

Very Water Resistant

For all skin types.

Drug Facts

Active ingredients

Octinoxate 7.5%

Oxybenzone 6.0%

Octisalate 5.0%

Zinc Oxide 3.3%

Octocrylene 2.0%

Purpose

Sunscreen

Use

Helps prevent sunburn.
Higher SPF gives more sunburn protection.

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.

When using this product keep out of eyes. Rinse with water to remove.

Do not use if allergic to any ingredient.

Stop use and ask a doctor if rash or irritation develops and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Shake well before each use.
Apply liberally to face and neck before sun exposure and as needed.
Reapply as needed or after towel drying, swimming or perspiring.
Children under 6 months of age: ask a doctor.

Other information

Store at controlled room temperature 15° - 30°C (59° - 86°F).
Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

Aloe Babadensis Leaf Juice, Bentonite, Butylene Glycol, C12-15Akyl Benzoate, Caffeine, Camellia Oleifera Leaf Extract, Cetyl Alcohol, Chlorphenesin, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Methyl Glucose Sesquistearate, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Phenoxyethanol, Picea Excelsa Wood Extract, Sodium Ascorbyl Phosphate, Sodium Borate, Sodium Cetearyl Sulfate, Sodium Hydroxide, Sodium Polyacrylate, Titanium Dioxide, Tocopheryl Acetate, VP/Eicosene Copolymer, Water/Aqua/Eau, Xanthan Gum

SkinMedica
Distributed in U.S.A. by
SkinMedica Aesthetics Inc.
Carlsbad, CA 92010
Made in U.S.A.
www.skinmedica.com
P3210-01

Principal Display Panel – 3 oz – Carton Label

SkinMedica

Environmental
Defense
Sunscreen™
SPF 50+
with UV ProPlex™

Full-spectrum UVA/UVB
protection strengthened
with antioxidant/free radical
defense in an elegant
oil-free and fragrance-free
formula.

Very Water-Resistant
Sun Protection

Net Wt. 85 g / 3 Oz.

Principal Display Panel – 3 oz – Carton Label

Principal Display Panel – 0.13 oz Box Samples

SkinMedica®

Environmental Defense
Sunscreen™ SPL 50+
with UV ProPlex™
Very Water-Resistant

12 x 0.13 Oz Samples

Principal Display Panel – 0.13 oz Box Samples

ENVIRONMENTAL DEFENSE SUNSCREEN SPF 50
octinoxate, oxybenzone, octisalate, zinc oxide, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:67402-051
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (Octinoxate)	Octinoxate	75 mg in 1 g
Oxybenzone (Oxybenzone)	Oxybenzone	60 mg in 1 g
Octisalate (Octisalate)	Octisalate	50 mg in 1 g
Zinc oxide (Zinc oxide)	Zinc oxide	33 mg in 1 g
Octocrylene (Octocrylene)	Octocrylene	20 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
aloe vera leaf
bentonite
butylene glycol
alkyl (C12-15) benzoate
caffeine
camellia oleifera leaf
cetyl alcohol
chlorphenesin
dimethicone
edetate disodium
ethylhexylglycerin
glycerin
glyceryl monostearate
phenoxyethanol
Picea abies wood
sodium ascorbyl phosphate
sodium borate
sodium cetostearyl sulfate
sodium hydroxide
sodium polyacrylate (8000 mw)
titanium dioxide
.ALPHA.-TOCOPHEROL ACETATE, DL-
water
xanthan gum

#	Item Code	Package Description
Packaging
1	NDC:67402-051-03	1 in 1 CARTON
1		85 g in 1 TUBE
2	NDC:67402-051-13	12 in 1 BOX
2		3.7 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/28/2010	01/01/2013

Labeler - Skinmedica Inc (124977005)

Registrant - AMCOL Health & Beauty Solutions, Incorporated (872684803)

Name	Address	ID/FEI	Business Operations
Establishment
AMCOL Health & Beauty Solutions, Incorporated		872684803	ANALYSIS(67402-051)

Revised: 10/2011

Document Id: d008af0e-3a11-4089-8cf0-3606d4602191

Set id: e2c3d128-26ed-4a48-bd64-57e12da843af

Version: 2

Effective Time: 20111017

Skinmedica Inc