FDA.reportPublic FDA data

Sage & Zinc Facial Hydrating Lotion SPF15

Manufacturer
Emeis Cosmetics Pty Ltd | Ensign Laboratories Proprietary Limited
Effective date
2025-12-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:26:37

Label at a glance#

ProductSage and Zinc Facial Hydrating SPF15
Active ingredientZINC OXIDE
Label structure9 sections

Indications and 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.

Dosage and administration

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...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 19.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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.

sage and zincsage and zinc

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76293-372-01Sage and Zinc Facial Hydrating SPF1557 g in 1 BOTTLE, PUMPLOTION573
76293-372-01Sage and Zinc Facial Hydrating SPF151 in 1 CARTONLOTION13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76293-37276293-372-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
CALCIUM CHLORIDEM4I0D6VV5MIACT
SOYBEANL7HT8F1ZODIACT
SODIUM CITRATE1Q73Q2JULRIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
XYLOSEA1TA934AKOIACT
CARROTL56Z1JK48BIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TOCOPHEROLR0ZB2556P8IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
MACADAMIA OIL515610SU8CIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
EVENING PRIMROSE OIL3Q9L08K71NIACT
SAGE OILU27K0H1H2OIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SODIUM GLUCONATER6Q3791S76IACT
SANTALUM SPICATUM OILH9LVS6REV4IACT
POLYSORBATE 60CAL22UVI4MIACT
GERANIOLL837108USYIACT
LUVISET 36005BG6GY6YKIACT
BETA CAROTENE01YAE03M7JIACT
LINALOOL, (+/-)-D81QY6I88EIACT
FARNESOLEB41QIU6JLIACT
LIMONENE, (+)-GFD7C86Q1WIACT
SACCHARIDE ISOMERATEW8K377W98IIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
PHENOXYETHANOLHIE492ZZ3TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SOYBEAN OIL241ATL177AIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
LAVENDER OILZBP1YXW0H8IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SQUALANEGW89575KF9IACT
OCTYLDODECYL XYLOSIDE8Z6VNR46QMIACT
ISOSTEARIC ACIDX33R8U0062IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
OCTYLDODECANOL461N1O614YIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sage and Zinc Facial Hydrating SPF15ZINC OXIDEEmeis Cosmetics Pty Ltdccabd647-ecdd-7230-e053-2a95a90a7a962025-12-18WarningsExact identifier
ndc (package): 76293-372-01
ndc (product): 76293-372
ndc11 (package): 76293037201
spl id: c082be90-3333-41de-9e24-6ee3d073e18b
spl set id: ccabd647-ecdd-7230-e053-2a95a90a7a96

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.