FDA.reportPublic FDA data

Sum 37 Micro Active Daily Moisture Sunscreen

Manufacturer
LG HOUSEHOLD & HEALTH CARE LTD. | fmg Co.Ltd
Effective date
2025-03-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:57:35

Label at a glance#

ProductSum 37 Micro Active Daily Moisture Sunscreen
Active ingredientOCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE
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 generously and evenly 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...

Storage and handling

Protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.7%
Homosalate 9%
Octisalate 4.5%
Octocrylene 9%

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

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION


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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

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

Directions

INSTRUCTIONS FOR USE SECTION

Apply generously and evenly 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: Ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER, GLYCERIN, DIMETHICONE, CETEARYL ALCOHOL, POTASSIUM CETYL PHOSPHATE, 1,2-HEXANEDIOL, BENZOTRIAZOLYL DODECYL P-CRESOL, PANTHENOL, GLYCERYL CAPRYLATE, ISODODECANE, GLYCERYL STEARATE, ACRYLATES/POLYTRIMETHYLSILOXYMETHACRYLATE COPOLYMER, CETEARYL OLIVATE, INULIN LAURYL CARBAMATE, SORBITAN OLIVATE, SODIUM POLYACRYLOYLDIMETHYL TAURATE, CITRUS AURANTIFOLIA (LIME) OIL, MAGNESIUM ALUMINUM SILICATE, TROMETHAMINE, XANTHAN GUM, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, PELARGONIUM GRAVEOLENS FLOWER OIL, TRISODIUM EDTA, VINEGAR, ANTHEMIS NOBILIS FLOWER OIL, BUTYLENE GLYCOL, ASIATICOSIDE, MADECASSIC ACID, ASIATIC ACID, PHLORETIN, 2,3-BUTANEDIOL, SACCHAROMYCES POLYPEPTIDES, LIMONENE, LINALOOL, CITRONELLOL, GERANIOL, CITRAL.

Other Information

STORAGE AND HANDLING SECTION


Protect the product in this container from excessive heat and direct sun

Questions?

OTC - QUESTIONS SECTION

1-866-993-4709

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

CartonCarton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53208-440-01Sum 37 Micro Active Daily Moisture Sunscreen50 mL in 1 BOTTLECREAM502
53208-440-02Sum 37 Micro Active Daily Moisture Sunscreen1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53208-440SUM 37 MICRO ACTIVE DAILY MOISTURE SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [LG HOUSEHOLD & HEALTH CARE LTD.]2Current NDC, 2 package rows20250323_2eea94e1-2409-8ad6-e063-6294a90a5df8.zip

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53208-44053208-440-01, 53208-440-02

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
TRISODIUM EDTA420IP921MBIACT
CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL39W1PKE3JIIACT
LAVANDULA ANGUSTIFOLIA (LAVENDER) OILZBP1YXW0H8IACT
PELARGONIUM GRAVEOLENS FLOWER OIL3K0J1S7QGCIACT
PANTHENOLWV9CM0O67ZIACT
ISODODECANEA8289P68Y2IACT
GLYCERYL STEARATE230OU9XXE4IACT
CETEARYL OLIVATE58B69Q84JOIACT
ASIATICOSIDEPKO39VY215IACT
BENZOTRIAZOLYL DODECYL P-CRESOL298PX4M11XIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
SODIUM POLYACRYLOYLDIMETHYL TAURATENG5NG5733TIACT
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
CITRUS AURANTIFOLIA (LIME) OILUZH29XGA8GIACT
PHLORETINS5J5OE47MKIACT
GERANIOLL837108USYIACT
CITRONELLOLP01OUT964KIACT
CITRALT7EU0O9VPPIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
ACETIC ACIDQ40Q9N063PIACT
ANTHEMIS NOBILIS FLOWER OILUB27587839IACT
GLYCERINPDC6A3C0OXIACT
TROMETHAMINE023C2WHX2VIACT
XANTHAN GUMTTV12P4NEEIACT
INULIN LAURYL CARBAMATE48RFF58ESGIACT
SORBITAN OLIVATEMDL271E3GRIACT
DIMETHICONE92RU3N3Y1OIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
LIMONENE, (+)-GFD7C86Q1WIACT
BUTYL ACRYLATE/METHYL METHACRYLATE/TRIMETHYLSILOXYMETHACRYLATE COPOLYMERY3BP59PMD3IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CETEARYL ALCOHOL2DMT128M1SIACT
LINALOOLD81QY6I88EIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
MADECASSIC ACIDM7O1N24J82IACT
2,3-BUTANEDIOL45427ZB5IJIACT
ASIATIC ACID9PA5A687X5IACT

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
Sum 37 Micro Active Daily Moisture SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG HOUSEHOLD & HEALTH CARE LTD.2eea94e1-2409-8ad6-e063-6294a90a5df82025-03-03WarningsExact identifier
ndc (package): 53208-440-02
ndc (package): 53208-440-01
ndc (product): 53208-440
ndc11 (package): 53208044001
ndc11 (package): 53208044002
spl id: 2f75b1e8-87b6-bd7d-e063-6294a90a0587
spl set id: 2eea94e1-2409-8ad6-e063-6294a90a5df8

Reported adverse events (FAERS/openFDA)#

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