TROPICAL VANILLA BODY SUNSCREEN BROAD SPECTRUM SPF 32- octinoxate, zinc oxide cream

Tropical Vanilla Body Sunscreen Broad Spectrum SPF 32 by

Drug Labeling and Warnings

Tropical Vanilla Body Sunscreen Broad Spectrum SPF 32 by is a Otc medication manufactured, distributed, or labeled by Eminence Organic Skin Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Vanilla Body Cream 5 oz

INGREDIENTS AND APPEARANCE

TROPICAL VANILLA BODY SUNSCREEN BROAD SPECTRUM SPF 32 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15751-2222
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	60 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
GLYCERIN (UNII: PDC6A3C0OX)
SHEA BUTTER (UNII: K49155WL9Y)
ALOE (UNII: V5VD430YW9)
CORN OIL (UNII: 8470G57WFM)
VITAMIN A (UNII: 81G40H8B0T)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
UBIDECARENONE (UNII: EJ27X76M46)
.ALPHA.-LIPOIC ACID (UNII: 73Y7P0K73Y)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
SORBITOL (UNII: 506T60A25R)
DIGLYCERIN (UNII: 3YC120743U)
LACTIC ACID (UNII: 33X04XA5AT)
LYSINE (UNII: K3Z4F929H6)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SOYBEAN OIL (UNII: 241ATL177A)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
VANILLA (UNII: Q74T35078H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15751-2222-5	1 in 1 BOX	06/27/2017
1		147 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/23/2012

Labeler - Eminence Organic Skin Care (205753317)