MedPath

Abib Watery hyaluron sunscreen Moisture tube

Approved
Approval ID

33d35125-eb1c-beef-e063-6394a90a2470

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 27, 2025

Manufacturers
FDA

Fourcompany Co., Ltd.

DUNS: 694864584

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Avobenzone, Homosalate, Octisalate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code73676-200
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Avobenzone, Homosalate, Octisalate
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 27, 2025
FDA Product Classification

INGREDIENTS (35)

BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
HYALURONIC ACIDInactive
Code: S270N0TRQY
Classification: IACT
NIACINAMIDEInactive
Code: 25X51I8RD4
Classification: IACT
BENZOTRIAZOLYL DODECYL P-CRESOLInactive
Code: 298PX4M11X
Classification: IACT
HYPROMELLOSE 2208 0.45% STEAROXY ETHERInactive
Code: MG58AH4FJ8
Classification: IACT
SILICA DIMETHYL SILYLATEInactive
Code: EU2PSP0G0W
Classification: IACT
ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OILInactive
Code: 8LGU7VM393
Classification: IACT
HYDROXYPROPYL METHYLCELLULOSEInactive
Code: 3NXW29V3WO
Classification: IACT
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATEInactive
Code: 75D21FL1PI
Classification: IACT
SODIUM HYALURONATEInactive
Code: YSE9PPT4TH
Classification: IACT
OCTISALATEActive
Quantity: 45 mg in 1 mL
Code: 4X49Y0596W
Classification: ACTIB
ASCORBYL GLUCOSIDEInactive
Code: 2V52R0NHXW
Classification: IACT
AVOBENZONEActive
Quantity: 28.5 mg in 1 mL
Code: G63QQF2NOX
Classification: ACTIB
HYDROXYACETOPHENONEInactive
Code: G1L3HT4CMH
Classification: IACT
ALCEA ROSEA FLOWERInactive
Code: 1250O8MKPZ
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYACRYLIC ACID (250000 MW)Inactive
Code: 9G2MAD7J6W
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
VINCETOXICUM ATRATUM WHOLEInactive
Code: U3176B0S5J
Classification: IACT
PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATEInactive
Code: 255PIF62MS
Classification: IACT
HOMOSALATEActive
Quantity: 135 mg in 1 mL
Code: V06SV4M95S
Classification: ACTIB
CHAMAECYPARIS OBTUSA OILInactive
Code: P2OMP71Y62
Classification: IACT
SODIUM ACETYLATED HYALURONATEInactive
Code: WN66R7GL93
Classification: IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERInactive
Code: W59H9296ZG
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMERInactive
Code: EG97988M5Q
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)Inactive
Code: JZ1374NL9E
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PENTYLENE GLYCOLInactive
Code: 50C1307PZG
Classification: IACT
1,2-HEXANEDIOLInactive
Code: TR046Y3K1G
Classification: IACT
POLYAMIDE-8 (4500 MW)Inactive
Code: 77723GV81A
Classification: IACT
COLLAGEN, SOLUBLE, FISH SKINInactive
Code: 8JC99XGU4W
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/30/2025

Abib
Watery hyaluron sunscreen
Moisture tube
Broad Spectrum SPF 30

1.69 FL. OZ. 50 mL

moisture tube

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/30/2025

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/30/2025

Active Ingredient

Avobenzone 2.85%,
Homosalate 13.50%,
Octisalate 4.50%

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/30/2025

Do not use

Do not use on damaged or broken skin

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/30/2025

Stop use

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/30/2025

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/30/2025

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

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/30/2025

When using

For external use only

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/30/2025

Inactive Ingredients

Water, Butylene Glycol, Acrylates Copolymer, Benzotriazolyl Dodecyl p-Cresol, Alcohol Denat., Methyl Methacrylate Crosspolymer, Pentylene Glycol, Cetyl Alcohol, 1,2-Hexanediol, Hydroxyacetophenone, Silica Dimethyl Silylate, Polyacrylic Acid, Chamaecyparis Obtusa Oil, Tromethamine, Ammonium Acryloyldimethyltaurate/VP Copolymer, Polyamide-8, Hydroxypropyl Methylcellulose, Butylene Glycol Dicaprylate/Dicaprate, Hydroxypropyl Methylcellulose Stearoxy Ether, Rosmarinus Officinalis (Rosemary) Leaf Oil, Xanthan Gum, Cynanchum Atratum Extract, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Ethylhexylglycerin, Althaea Rosea Flower Extract, Ascorbic Acid, Ascorbyl Glucoside, Niacinamide, Hyaluronic Acid, Hydrolyzed Hyaluronic Acid, Collagen Extract, Sodium Hyaluronate

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/30/2025

Directions

1.Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every two hours

2.Use a water-resistant sunscreen if swimming or sweating

3.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

6.Children under 6 months of age: Ask a doctor

WARNINGS SECTION

LOINC: 34071-1Updated: 5/30/2025

Warnings

  • 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.

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