Tropical Vanilla Sunscreen Broad Spectrum SPF 32

Dosage form: cream
Ingredients: OCTINOXATE 6mL in 100mL, ZINC OXIDE 5mL in 100mL
Labeler: Eminence Organic Skin Care
NDC Code: 15751-2223

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.

Tropical Vanilla Sunscreen Cream Broad Spectrum SPF 32

Drug Facts


Active Ingredients

Octinoxate 6%

Zinc Oxide 5%

Purpose

Sunscreen

Uses
  • helps prevent sunscreen
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by 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 Poison Control Center right away.

Directions
  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
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
  • Children under 6 months of age: Ask a doctor

Other Information

Protect the product in this container from excessive heat and direct sun

Inactive Ingredients

Linden Flower Tea, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Sodium Cetearyl Sulfate, Glycerin, Shea Butter, Aloe Leaf Juice, Corn Germ Oil, Vitamin A, Vitamin C Ester, Vitamin E, Coenzyme Q10, Alpha Lipoic Acid, Glyceryl Stearate, Hydrolyzed Wheat Protein, Sorbitol, Diglycerin, Lactic Acid, Lysine, Sodium PCA, Soybean Oil, Methyl Glucose Sesquistearate, Xanthan Gum, Caprylyl Glycol, Vanilla Extract, Lecithin

Distributed by Eminence Organic Skin Care #300 – 530 West Broadway Vancouver, BC, Canada V5Z 1E9 www.eminenceorganics.com Made in Hungary 1-888-747-6342 (US & Canada Toll Free)

Pamper your skin with this sunscreen cream, which contains herbal ingredients, specifically designed for the face. Hydrating and revitalizing shea butter combines with the fragrant aroma of vanilla to care for your skin while the SPF 32 formula defends against the sun’s harmful rays.

Suitable for all skin types.
 
Note: Store in controlled temperatures (39–68°F/4–20°C). Keep in a dark and dry place. Keep container
tightly closed.
 
Our products contain all organic fruits, vegetables and herbs. They do not contain harmful chemicals
or animal by-products. They are not tested on animals and are packaged in environmentally friendly packaging.

Do not use if printed seal under cap is broken or missing.

Tropical Vanilla Sunscreen Cream Broad Spectrum SPF 32 2oz/60ml (15751-2223-2) / Tropical Vanilla Sunscreen Cream Broad Spectrum SPF 32 4.2oz/125ml (15751-2223-4)


TROPICAL VANILLA SUNSCREEN BROAD SPECTRUM SPF 32 
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15751-2223
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE6 mL  in 100 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TILIA CORDATA FLOWER 
MEDIUM-CHAIN TRIGLYCERIDES 
CETOSTEARYL ALCOHOL 
SODIUM CETOSTEARYL SULFATE 
GLYCERIN 
SHEA BUTTER 
ALOE 
CORN 
VITAMIN A 
ASCORBIC ACID 
ALPHA-TOCOPHEROL 
UBIDECARENONE 
.ALPHA.-LIPOIC ACID 
GLYCERYL MONOSTEARATE 
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) 
SORBITOL 
DIGLYCERIN 
LACTIC ACID 
LYSINE 
SODIUM PYRROLIDONE CARBOXYLATE 
SOYBEAN OIL 
XANTHAN GUM 
CAPRYLYL GLYCOL 
VANILLA 
Packaging
#Item CodePackage Description
1NDC:15751-2223-260 mL in 1 JAR
2NDC:15751-2223-4125 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/07/2012
Labeler - Eminence Organic Skin Care (205753317)
Registrant - Eminence Organic Skin Care (205753317)

Revised: 03/2012
 
Eminence Organic Skin Care

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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