Environmental Defense Sunscreen SPF 50

Dosage form: cream
Ingredients: Octinoxate 75mg in 1g, Oxybenzone 60mg in 1g, Octisalate 50mg in 1g, Zinc oxide 3.3mg in 1g, Octocrylene 2.0mg in 1g
Labeler: Skinmedica Inc
NDC Code: 67402-051

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.

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

Sunscreen

Sunscreen

Sunscreen

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 – 0.13 oz Box Samples

SkinMedica®

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

12 x 0.13 Oz Samples

ENVIRONMENTAL DEFENSE SUNSCREEN SPF 50 
octinoxate, oxybenzone, octisalate, zinc oxide, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67402-051
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate75 mg  in 1 g
Oxybenzone (Oxybenzone) Oxybenzone60 mg  in 1 g
Octisalate (Octisalate) Octisalate50 mg  in 1 g
Zinc oxide (Zinc oxide) Zinc oxide3.3 mg  in 1 g
Octocrylene (Octocrylene) Octocrylene2.0 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 
Packaging
#Item CodePackage Description
1NDC:67402-051-031 TUBE (1 TUBE) in 1 CARTON
185 g in 1 TUBE
2NDC:67402-051-1312 TUBE (12 TUBE) in 1 BOX
23.7 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/28/2010
Labeler - Skinmedica Inc (124977005)
Registrant - AMCOL Health & Beauty Solutions, Incorporated (872684803)
Establishment
NameAddressID/FEIOperations
AMCOL Health & Beauty Solutions, Incorporated872684803ANALYSIS

Revised: 10/2011
 
Skinmedica Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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