Label: CARECELLA SUN CREAM- amiloxate, ethylhexyl triazone cream
- NDC Code(s): 69422-1006-1, 69422-1006-2
- Packager: General Bio Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated January 8, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
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
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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
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INGREDIENTS AND APPEARANCE
CARECELLA SUN CREAM
amiloxate, ethylhexyl triazone creamProduct 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)