SAGE AND ZINC FACIAL HYDRATING SPF 15- zinc oxide cream

Sage And Zinc Facial Hydrating by

Drug Labeling and Warnings

Sage And Zinc Facial Hydrating by is a Otc medication manufactured, distributed, or labeled by Emeis Cosmetics Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Zinc Oxide 16.1%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.

Warnings

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

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
• Use a water resistant sunscreen if swimming or sweating
• Reapply at least every 2 hours
• Children under 6 months of age: Ask a doctor

Other information

• Protect the product in this container from excessive heat and direct sun.
• You may report a serious adverse reaction to Report Reaction LLC, PO Box 22, Plainsboro, NJ 08536-0222.

Inactive ingredients

Water, Caprylic/Capric Triglyceride, PEG-100 Stearate, Glycerin, Cetearyl Alcohol, Potassium Cetyl Phosphate, Macadamia Ternifolia Seed Oil, Squalane, Hydrogenated Palm Glycerides, Phenoxyethanol, Tocopheryl Acetate, Lauryl Pyrrolidone, Oenothera Biennis (Evening Primrose) Oil, Silica, Citric Acid, Lavandula Angustifolia (Lavender) Oil, 1,2-Hexanediol, Salvia Officinalis (Sage) Oil, Tocopherol, Disodium EDTA, Xanthan Gum, Glycine Soja (Soybean) Oil, Fusanus Spicatus Wood Oil, Caprylyl Glycol, Magnesium Aluminum Silicate, Ethylhexylglycerin, Glycine Soja (Soybean) Seed Extract, Daucus Carota Sativa (Carrot) Root Extract, Beta-Carotene.

SPL UNCLASSIFIED SECTION

Manufactured in Australia.
Aesop, 25 Smith Street, Fitzroy 3065 Australia.

PRINCIPAL DISPLAY PANEL - 47 g Tube Carton

Aēsop®

Sage & Zinc Facial Hydrating Cream with Sunscreen
SPF
15

Zinc Oxide Tocopheryl Acetate Sage Leaf

Daily moisturising sunscreen SPF15 for all skin types. A hydrating blend of superior botanicals including Sage Leaf and
Sandalwood, with the benefits of Zinc Oxide.

Massage evenly over the face from forehead to neck after cleansing and reapply during the day to maintain protection. Enhanced
with plant-derived vitamins including Vitamin E, this cream with mineral-based sunscreen is ideal for city living.

www.aesop.com
Net Wt. 47 g / 1.6 Oz.

INGREDIENTS AND APPEARANCE

SAGE AND ZINC FACIAL HYDRATING  SPF 15
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76293-037
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.26 g  in 1.54 g

Inactive Ingredients
Ingredient Name	Strength
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Water (UNII: 059QF0KO0R)
PEG-100 Stearate (UNII: YD01N1999R)
Glycerin (UNII: PDC6A3C0OX)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
Macadamia Oil (UNII: 515610SU8C)
Squalane (UNII: GW89575KF9)
Hydrogenated Palm Glycerides (UNII: YCZ8EM144Q)
Phenoxyethanol (UNII: HIE492ZZ3T)
.Alpha.-Tocopherol Acetate, DL- (UNII: WR1WPI7EW8)
Lauryl Pyrrolidone (UNII: 3P14VW8FNY)
Evening Primrose Oil (UNII: 3Q9L08K71N)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Lavender Oil (UNII: ZBP1YXW0H8)
1,2-Hexanediol (UNII: TR046Y3K1G)
Sage Oil (UNII: U27K0H1H2O)
Tocopherol (UNII: R0ZB2556P8)
Edetate Disodium (UNII: 7FLD91C86K)
Xanthan Gum (UNII: TTV12P4NEE)
Soybean Oil (UNII: 241ATL177A)
Santalum Spicatum Oil (UNII: H9LVS6REV4)
Caprylyl Glycol (UNII: 00YIU5438U)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
Ethylhexylglycerin (UNII: 147D247K3P)
Soybean (UNII: L7HT8F1ZOD)
Carrot (UNII: L56Z1JK48B)
Beta Carotene (UNII: 01YAE03M7J)

Product Characteristics
Color	YELLOW (Pale yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76293-037-56	12 in 1 CARTON
1	NDC: 76293-037-74	71 g in 1 JAR
2	NDC: 76293-037-63	24 in 1 CARTON
2	NDC: 76293-037-42	47 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2012

Labeler - Emeis Cosmetics Pty Ltd (754271146)