EMINENCE RED CURRANT PROTECTIVE MOISTURIZER- octinoxate, zinc oxide cream

EMINENCE Red Currant Protective Moisturizer by

Drug Labeling and Warnings

EMINENCE Red Currant Protective Moisturizer by is a Otc medication manufactured, distributed, or labeled by Eminence Organic Skin Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EMINENCE Red Currant Protective Moisturizer

Drug Facts

Active Ingredients

Octinoxate 6%

Zinc Oxide 4.5%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• 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 a 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

Elderflower Tea, Hydrolyzed Wheat Protein, Sorbitol, Lysine, PCA, Diglycerin, Lactic Acid, Glyceryl Stearate, Propanediol, Coco Caprylate/

Caprate, Caprylic/Capric Triglyceride, Cetyl Stearyl Alcohol, Stearic Acid, Tocopheryl Acetate, Elderflower Extract, Red Currant Extract, Xanthan

Gum, Vitamin A, Vitamin C Ester, Vitamin E, Coenzyme Q10, Alpha Lipoic Acid, Modified Corn Starch, Beet Root Juice, Sodium Salicylate, Magnolia Bark Extract, Grape Seed Extract, Tocopherol, Lecithin, Maltodextrin, Water, Menthol, Elderflower Essence, Microencapsulated Tea Tree Oil.

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 and Canada Toll Free)

Note:

Store in controlled temperatures (39–68°F/4–20°C). Keep in a dark and dry place. Keep container tightly closed.

SPL UNCLASSIFIED SECTION

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.

Red Currant Protective Moisturizer 2 oz

Red Currant Protective Moisturizer 4.2 oz

Red Currant Protective Moisturizer 0.5 oz

INGREDIENTS AND APPEARANCE

EMINENCE RED CURRANT PROTECTIVE MOISTURIZER 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15751-2286
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	45 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
SORBITOL (UNII: 506T60A25R)
LYSINE (UNII: K3Z4F929H6)
DIGLYCERIN (UNII: 3YC120743U)
LACTIC ACID (UNII: 33X04XA5AT)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PROPANEDIOL (UNII: 5965N8W85T)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
RED CURRANT (UNII: Q5YG47WU3D)
XANTHAN GUM (UNII: TTV12P4NEE)
VITAMIN A (UNII: 81G40H8B0T)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
UBIDECARENONE (UNII: EJ27X76M46)
.ALPHA.-LIPOIC ACID (UNII: 73Y7P0K73Y)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)
BEET JUICE (UNII: IOZ32L9H3O)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)
GRAPE SEED OIL (UNII: 930MLC8XGG)
TOCOPHEROL (UNII: R0ZB2556P8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
WATER (UNII: 059QF0KO0R)
MENTHOL (UNII: L7T10EIP3A)
TEA TREE OIL (UNII: VIF565UC2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15751-2286-2	1 in 1 BOX	08/22/2013
1		60 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC: 15751-2286-4	1 in 1 BOX	08/22/2013
2		125 mL in 1 JAR; Type 0: Not a Combination Product
3	NDC: 15751-2286-6	15 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package	08/22/2013	09/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/22/2013

Labeler - Eminence Organic Skin Care (205753317)