CARECELLA SUN CREAM- amiloxate, ethylhexyl triazone cream 
General Bio Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Carecella Daily Sun Cream

Amiloxate (7.49%) ------------------------------------------------------------------------------- Sunscreen

Ethylhexyl Triazone (4.5%) -------------------------------------------------------------------- Sunscreen

Sunscreen

Helps to prevent sunburn

For external use only.

  • if you are allergic to any of the ingredients
  • on damaged or broken skin

  • keep out of eyes. Rinse with water to remove.

  • rash or irritation develops and lasts.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Apply liberally onto the cleansed entire face and neck 15 minutes prior to sun exposure.
  • Reapply as needed or after towel drying, swimming, or sweating.
  • Reapply at least every 2 hours: “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.; and wear long-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months: Ask a doctor.

  • Store in a cool dry place away from direct sunlight.
  • “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.”

Centella Asiatica (Gotu Kola) Leaf Extract, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Butylene Glycol, Propanediol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Dibutyl Adipate, Ethanol, C13-16 Isoalkane, Niacinamde, Water, Silicon Dioxide, Alkyl (C12-15) Benzoate, Dipropylene Glycol, Dicaprylyl Carbonate, Poly C10-30 Alkyl Acrylate, Medium-Chain Triglycerides, Heptyl Undecylenate, Cetostearyl Alcohol, 1,2-Hexanediol, Hydroxyacetophenone, Polyglyceryl-3 Methylglucose Distearate, Candida Bombicola/Glucose/Methyl Rapeseedate Ferment, Glyceryl Monostearate, Oryza Sativa (Rice) Germ Oil, Coconut Oil, Hydrogenated Vegetable Oil, Ammonium Acryloyldimethyltaurate/VP Copolymer, Polyacrylate Crosspolymer-6, Docosanol, Sodium Acrylate/Sodium Acryloyldimethyltaurate Copolymer, Polyisobutylene, Stearic Acid, Caprylyl Glycol, Schisandra Chinensis (Schizandra Berry) Seed Extract, Glycyrrhizinate Dipotassium, Tocopherol, Adenosine, Centella Asiatica (Gotu Kola) Extract, Sunflower Oil, Vincetoxicum Atratum (Swallowwort) Whole Extract, Caprylyl/Capryl Oligoglucoside, Sorbitan Monooleate, Madecassoside, Asiaticoside, t-Butyl Alcohol, Madecassic Acid, Asiatic Acid, Phytosphingosine

Carecella Daily Sun Cream

CaraCella Sun Cream

CARECELLA SUN CREAM 
amiloxate, ethylhexyl triazone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69422-1006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMILOXATE (UNII: 376KTP06K8) (AMILOXATE - UNII:376KTP06K8) AMILOXATE7.49 g  in 100 mL
ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4) (ETHYLHEXYL TRIAZONE - UNII:XQN8R9SAK4) ETHYLHEXYL TRIAZONE4.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (UNII: W19EIO0DBE)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)  
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
PROPANEDIOL (UNII: 5965N8W85T)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
BEMOTRIZINOL (UNII: PWZ1720CBH)  
DIBUTYL ADIPATE (UNII: F4K100DXP3)  
ALCOHOL (UNII: 3K9958V90M)  
C13-16 ISOPARAFFIN (UNII: LED42LZG6O)  
NIACINAMIDE (UNII: 25X51I8RD4)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
WATER (UNII: 059QF0KO0R)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
RICE GERM OIL (UNII: D4H5GGS5JF)  
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69422-1006-21 in 1 BOX07/19/2023
1NDC:69422-1006-150 mL in 1 TUBE; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/19/202307/17/2024
Labeler - General Bio Co., Ltd. (695273863)
Registrant - General Bio Co., Ltd. (695273863)
Establishment
NameAddressID/FEIBusiness Operations
General Bio Co., Ltd.695273863manufacture(69422-1006)

Revised: 7/2024
 
General Bio Co., Ltd.