CARECELLA SUN CREAM- amiloxate, ethylhexyl triazone cream

Carecella Sun Cream by

Drug Labeling and Warnings

Carecella Sun Cream by is a Otc medication manufactured, distributed, or labeled by General Bio Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps to prevent sunburn

WARNINGS

For external use only.

DO NOT USE

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

WHEN USING

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

STOP USE

• rash or irritation develops and lasts.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

• 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.

OTHER SAFETY INFORMATION

• 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.”

INACTIVE INGREDIENT

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

INGREDIENTS AND APPEARANCE

CARECELLA SUN CREAM 
amiloxate, ethylhexyl triazone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69422-1006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMILOXATE (UNII: 376KTP06K8) (AMILOXATE - UNII:376KTP06K8)	AMILOXATE	7.49 g  in 100 mL
ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4) (ETHYLHEXYL TRIAZONE - UNII:XQN8R9SAK4)	ETHYLHEXYL TRIAZONE	4.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69422-1006-2	1 in 1 BOX	07/19/2023
1	NDC: 69422-1006-1	50 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
unapproved drug other		07/19/2023

Labeler - General Bio Co., Ltd. (695273863)

Registrant - General Bio Co., Ltd. (695273863)

Establishment
Name	Address	ID/FEI	Business Operations
General Bio Co., Ltd.		695273863	manufacture(69422-1006)