SUM 37 MICRO ACTIVE DAILY MOISTURE SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene cream

Sum 37 Micro Active Daily Moisture Sunscreen by

Drug Labeling and Warnings

Sum 37 Micro Active Daily Moisture Sunscreen by is a Otc medication manufactured, distributed, or labeled by LG HOUSEHOLD & HEALTH CARE LTD., fmg Co.Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

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

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 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

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

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

Questions?

1-866-993-4709

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUM 37 MICRO ACTIVE DAILY MOISTURE SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53208-440
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	90 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	27 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	90 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TRISODIUM EDTA (UNII: 420IP921MB)
CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL (UNII: 39W1PKE3JI)
LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL (UNII: ZBP1YXW0H8)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
PANTHENOL (UNII: WV9CM0O67Z)
ISODODECANE (UNII: A8289P68Y2)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
ASIATICOSIDE (UNII: PKO39VY215)
BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
SODIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: NG5NG5733T)
CITRUS AURANTIFOLIA (LIME) OIL (UNII: UZH29XGA8G)
PHLORETIN (UNII: S5J5OE47MK)
GERANIOL (UNII: L837108USY)
CITRONELLOL (UNII: P01OUT964K)
CITRAL (UNII: T7EU0O9VPP)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
ACETIC ACID (UNII: Q40Q9N063P)
ANTHEMIS NOBILIS FLOWER OIL (UNII: UB27587839)
GLYCERIN (UNII: PDC6A3C0OX)
TROMETHAMINE (UNII: 023C2WHX2V)
XANTHAN GUM (UNII: TTV12P4NEE)
INULIN LAURYL CARBAMATE (UNII: 48RFF58ESG)
SORBITAN OLIVATE (UNII: MDL271E3GR)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
BUTYL ACRYLATE/METHYL METHACRYLATE/TRIMETHYLSILOXYMETHACRYLATE COPOLYMER (UNII: Y3BP59PMD3)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
LINALOOL (UNII: D81QY6I88E)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MADECASSIC ACID (UNII: M7O1N24J82)
2,3-BUTANEDIOL (UNII: 45427ZB5IJ)
ASIATIC ACID (UNII: 9PA5A687X5)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53208-440-02	1 in 1 CARTON	03/10/2025
1	NDC: 53208-440-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/10/2025

Labeler - LG HOUSEHOLD & HEALTH CARE LTD. (688276187)

Establishment
Name	Address	ID/FEI	Business Operations
fmg Co.Ltd		690188305	manufacture(53208-440)