Verdon Outdoor Moisturizer SPF 30

Dosage form: cream
Ingredients: OCTOCRYLENE 100mg in 1mL, OCTINOXATE 75mg in 1mL, TITANIUM DIOXIDE 43mg in 1mL, ENSULIZOLE 30mg in 1mL
Labeler: LABORATOIRES M&L
NDC Code: 10345-020

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.

Verdon Outdoor Moisturizer SPF 30

ACTIVE INGREDIENTS:

OCTOCRYLENE                                                                              10%   
ETHYLHEXYL METHOXYCINNAMATE/OCTINOXATE             7.5%  
TITANIUM DIOXIDE                                                                      4.3%   
PHENYLBENZIMIDAZOLE SULFONIC ACID/ENSULIZOLE        3%    

Uses:

- Helps prevent sunburn. 

- Higher SPF gives more sunburn protection. 

- Provides moderate protection against sun burn.

Warnings:

For external use only.

When using this product:

- Keep out of eyes. Rinse with water to remove.

Stop use and ask 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:

- Apply evenly each morning before sun exposure. Reapply as needed.  - Do not use on infants  under 6 months.  - Reapply as needed or after towel drying, swimming or sweating.

Other information

High sun protection product. Sun alert: Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the rises of skin aging, skin cancer and other harmful effects of the sun.

Inactive Ingredients:

Aqua/Water - Cyclomethicone - Glycerin - C12-15 Alkyl Benzoate - Dimethicone - Alcohol - Glyceryl Stearate - Caprylic/Capric Triglyceride - Cetearyl Alcohol - Potassium Cetyl Phosphate - PEG-100 Stearate - PEG-20 Methyl Glucose Sesquistearate - Lauroyl Lysine -VP/eicosene Copolymer - Hippophae Rhamnoides Fruit Juice - Hippophae Rhamnoides Oil - Mentha Piperita (Peppermint) oil* - Artemisia Umbelliformis Flower Extract* - Citrus Aurantium Dulcis (Orange) Fruit Extract - Salvia Sclarea Oil - Mentha Viridis (Spearmint) Leaf Oil - Lavandula Hybrida Oil - Alumina - Parfum/Fragrance - Stearic Acid - Cetearyl Glucoside - Chlorphenesin - Ethylhexylglycerin - Sodium Benzoate - Potassium Sorbate - Sodium Hydroxide - Phenoxyethanol - Tocopherol - Xanthan Gum - Zinc PCA - Alpha-Isomethyl Ionone - Benzyl Salicylate - Benzyl Alcohol - Limonene - Linalool - Hydroxycitronellal - Geraniol - Citral. *Ingredients from Organic Farming.

Purpose

Sunscreen

Product Container Label

VERDON OUTDOOR MOISTURIZER SPF 30  
octocrylene, octinoxate, titanium dioxide, ensulizole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10345-020
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE100 mg  in 1 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE75 mg  in 1 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE43 mg  in 1 mL
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 
GLYCERIN 
ALKYL (C12-15) BENZOATE 
DIMETHICONE 
ALCOHOL 
GLYCERYL MONOSTEARATE 
MEDIUM-CHAIN TRIGLYCERIDES 
CETOSTEARYL ALCOHOL 
POTASSIUM CETYL PHOSPHATE 
PEG-100 STEARATE 
LAUROYL LYSINE 
HIPPOPHAE RHAMNOIDES FRUIT JUICE 
HIPPOPHAE RHAMNOIDES FRUIT OIL 
PEPPERMINT OIL 
ARTEMISIA UMBELLIFORMIS FLOWER 
ORANGE 
CLARY SAGE OIL 
SPEARMINT OIL 
LAVANDIN OIL 
ALUMINUM OXIDE 
STEARIC ACID 
CETEARYL GLUCOSIDE 
CHLORPHENESIN 
ETHYLHEXYLGLYCERIN 
SODIUM BENZOATE 
POTASSIUM SORBATE 
SODIUM HYDROXIDE 
PHENOXYETHANOL 
TOCOPHEROL 
XANTHAN GUM 
ZINC PIDOLATE 
ISOMETHYL-.ALPHA.-IONONE 
BENZYL SALICYLATE 
BENZYL ALCOHOL 
LINALOOL, (+/-)- 
HYDROXYCITRONELLAL 
GERANIOL 
CITRAL 
Packaging
#Item CodePackage Description
1NDC:10345-020-011 BOTTLE (BOTTLE) in 1 PACKAGE
150 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/14/2011
Labeler - LABORATOIRES M&L (262533623)

Revised: 04/2013
 
LABORATOIRES M&L

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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