CENTELLA CALMING SUNSCREEN cream

Centella Calming SUNSCREEN by

Drug Labeling and Warnings

Centella Calming SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Zinc Oxide 2.85%
Titanium Dioxide 2.76%
EthylhexyI Salicylate 5%
Phenylbenzimidazole Sulfonic Acid 3.2%

Purpose

Sunscreen

Use

● Helps prevent sunburn.
● Ifused 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

Do not use on damaged or broken skin

WHEN USING

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

STOP USE

Stop use and ask a doctor if rash occurs

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

Directions

●Apply liberally 15 minutes before sun exposure.

●Children under 6 months of age : Ask a doctor.
●Reapply at least every 2 hours, and after 40 minutes of 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 of 15 or higher and other sun protection measures including:
●limit time in the sun, especially from10 a.m.-2 p.m.
●wear long-sleeve shirts, pants, hats, and sunglasses

Other information

●Protect the product in this container from excessive heat and direct sun.
●Sun alert : Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the
risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

Aqua, Glycerin, Silica, Butylene Glycol, Neopenty|l Gly-col Diheptanoate, Cyclopentasiloxane, Isohexadecane,
Cety| Peg/Ppg-10/1 Dimethicone, C12-15 AlkyI Benzo-ate, Cyclohexasiloxane, Niacinamide, Magnesium Sul-
fate, Disteardimonium Hectorite, Madecassoside,1,2-Hexanediol, Peg-10 Dimethicone, Sorbitan Sesqui-
oleate, Hydroxyacetophenone, Sodium Hydroxide,

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

CENTELLA CALMING SUNSCREEN 
centella calming sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84558-007
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.76 g  in 100 mL
ETHYLHEXYL SALICYLATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	ETHYLHEXYL SALICYLATE	5 g  in 100 mL
PHENYLBENZIMIDAZOLE SULFONIC ACID (UNII: 9YQ9DI1W42) (PHENYLBENZIMIDAZOLE SULFONIC ACID - UNII:9YQ9DI1W42)	PHENYLBENZIMIDAZOLE SULFONIC ACID	3.2 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.85 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
PROPANEDIOL (UNII: 5965N8W85T)
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
SODIUM S-(2-HYDROXY-3-(3-(TRIHYDROXYSILYL)PROPOXY)PROPYL) SULFUROTHIOATE (UNII: 2V56GQW1BM)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LACTIC ACID (UNII: 33X04XA5AT)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
HYDROLYZED CASEIN (ENZYMATIC; 1000 MW) (UNII: M93H91U80R)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
HYALURONIC ACID (UNII: S270N0TRQY)
AQUA (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SILICA (UNII: ETJ7Z6XBU4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
ISOHEXADECANE (UNII: 918X1OUF1E)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
NIACINAMIDE (UNII: 25X51I8RD4)
MAGNESIUM SULFATE (UNII: DE08037SAB)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MADECASSOSIDE (UNII: CQ2F5O6YIY)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84558-007-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/10/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/10/2025

Labeler - GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd (545488483)

Establishment
Name	Address	ID/FEI	Business Operations
GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd		545488483	manufacture(84558-007)