CENTELLA RELIEF SOOTHING SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion

CENTELLA RELIEF SOOTHING SUNSCREEN by

Drug Labeling and Warnings

CENTELLA RELIEF SOOTHING SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by IUNIK Co., Ltd., COSMAX, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Avobenzone 2.84%

Homosalate 7.0 %

Octisalate 4.5%

Octocrylene 9.0%

PURPOSE

Sunscreen

USES

- Helps prevent sunburn.

- If used as directed with other sun protection measures (see Directions), decrease 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.

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

• Apply liberally 15 minutes before sun exposure.
• 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 of age: Ask a doctor.
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating.

INACTIVE INGREDIENTS

Water, Tripropylene Glycol, Propanediol, Silica, Ethylhexyl Methoxycrylene, Diethylhexy 2,6-Naphthalate, 1,2-Hexanediol, Enantia Chlorantha Bark Extract, Centella Asiatica Extract, Centella Asiatica Leaf Extract, Centella Asiatica Root Extract, Saccharomyces Ferment, Dimethicone, Methyl Trimethicone, Pentylene Glycol, Hydroxyethyl Urea, Poly C10-30 Alky Acrylate, Cetearyl Olivate, Polyacrylic Acid, Tromethamine, Sorbitan Olivate, Dipotassium Phosphate, Acetyl Glutamine, Sodium Stearoyl Glutamate, Butylene Glycol, Ethylhexylglycerin, Cellulose Gum, Tocopherol, Oleanolic Acid, Asiatic Acid, Asiaticoside, Madecassic Acid, Madecassoside, Cetyl Alcohol, Carborer, Xanthan Gum

CENTELLA RELIEF SOOTHING SUNSCREEN

INGREDIENTS AND APPEARANCE

CENTELLA RELIEF SOOTHING SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83403-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.85 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TRIPROPYLENE GLYCOL (UNII: 3C8845E7C1)
MADECASSOSIDE (UNII: CQ2F5O6YIY)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
CARBOMER (UNII: 0A5MM307FC)
CENTELLA ASIATICA ROOT (UNII: 8MXU1P42J0)
ASIATICOSIDE (UNII: PKO39VY215)
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
SILICA (UNII: ETJ7Z6XBU4)
MADECASSIC ACID (UNII: M7O1N24J82)
TOCOPHEROL (UNII: R0ZB2556P8)
PROPANEDIOL (UNII: 5965N8W85T)
BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)
CETYL ALCOHOL (UNII: 936JST6JCN)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
CELLULOSE GUM (UNII: K679OBS311)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
ASIATIC ACID (UNII: 9PA5A687X5)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
TROMETHAMINE (UNII: 023C2WHX2V)
SORBITAN OLIVATE (UNII: MDL271E3GR)
ACETYL GLUTAMINE (UNII: 01J18G9G97)
XANTHAN GUM (UNII: TTV12P4NEE)
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83403-100-02	1 in 1 BOX	01/07/2026
1	NDC: 83403-100-01	60 mL in 1 TUBE; 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	01/07/2026

Labeler - IUNIK Co., Ltd. (695653625)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX, INC.		689049693	manufacture(83403-100)