SAGE AND ZINC FACIAL HYDRATING SPF15- zinc oxide lotion

Sage and Zinc Facial Hydrating SPF15 by

Drug Labeling and Warnings

Sage and Zinc Facial Hydrating SPF15 by is a Otc medication manufactured, distributed, or labeled by Emeis Cosmetics Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Zinc Oxide 19.5%

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 the 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.
• Children under 6 months of age: Ask a doctor.
• Reapply:
• At least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating.
• Sun Protection Measures. Spending time in the sun increases 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-sleeve shirts, pants, hats and sunglasses.

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 (Aqua), Glycerin, Coco-Caprylate/Caprate, Octyldodecanol, Acrylates Copolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Macadamia Integrifolia Seed Oil, Squalane, Polyglyceryl-3 Polyricinoleate, Octyldodecyl Xyloside, PEG-30 Dipolyhydroxystearate, Phenoxyethanol, Tocopheryl Acetate, Saccharide Isomerate, Oenothera Biennis (Evening Primrose) Oil, Silica, Isostearic Acid, Lavandula Angustifolia (Lavender) Oil, Glycine Soja (Soybean) Oil, Salvia Officinalis (Sage) Oil, 1,2-Hexanediol, Caprylyl Glycol, Sodium Gluconate, Fusanus Spicatus Wood Oil, Tocopherol, Polysorbate 60, Sorbitan Isostearate, Ethylhexylglycerin, Calcium Chloride, Glycine Soja (Soybean) Seed Extract, Citric Acid, Sodium Citrate, Potassium Sorbate, Xylose, Beta-Carotene, Daucus Carota Sativa (Carrot) Root Extract, Linalool, Farnesol, Limonene, Geraniol.

Company Information

Manufactured in Australia.

Aesop, 25 Smith Street,

Fitzroy 3065, Australia.

+61 3 9412 8900

aesop@aesop.com

Distributed by Aesop USA Inc,

48 West 25th St. New York, NY,

10010

Product Packaging

Aesop.

SPF 15 Sage & Zinc Facial Hydrating Lotion

Zinc Oxide

Tocopheryl Acetate

Sage Leaf

Broad-spectrum SPF15 Sunscreen

Daily-use moisturiser providing mineral-based, SPF15 sunscreen protection. Suitable for most skin types, including sensitive. Massage evenly over the face and neck after cleansing and reapply during the day to maintain protection

aesop.com

Net wt. 57 g/2.0Oz.

INGREDIENTS AND APPEARANCE

SAGE AND ZINC FACIAL HYDRATING SPF15 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76293-372
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	195 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
SOYBEAN (UNII: L7HT8F1ZOD)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
XYLOSE (UNII: A1TA934AKO)
CARROT (UNII: L56Z1JK48B)
TOCOPHEROL (UNII: R0ZB2556P8)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
MACADAMIA OIL (UNII: 515610SU8C)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SAGE OIL (UNII: U27K0H1H2O)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM GLUCONATE (UNII: R6Q3791S76)
SANTALUM SPICATUM OIL (UNII: H9LVS6REV4)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
LUVISET 360 (UNII: 05BG6GY6YK)
BETA CAROTENE (UNII: 01YAE03M7J)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
FARNESOL (UNII: EB41QIU6JL)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
GERANIOL (UNII: L837108USY)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
SOYBEAN OIL (UNII: 241ATL177A)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SQUALANE (UNII: GW89575KF9)
OCTYLDODECYL XYLOSIDE (UNII: 8Z6VNR46QM)
ISOSTEARIC ACID (UNII: X33R8U0062)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECANOL (UNII: 461N1O614Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76293-372-01	1 in 1 CARTON	01/01/2022
1		57 g in 1 BOTTLE, PUMP; 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	01/01/2022

Labeler - Emeis Cosmetics Pty Ltd (754271146)