CARECELLA DAY CREAM- avobenzone, octinoxate, octocrylene cream 
General Bio Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CareCella Day Cream

​Drug Facts

​Active ingredients

Avobenzone 3%

Octinoxate 7.5%

Octocrylene 7.5%

​Purpose

Sunscreen

​Uses

• helps prevent sunburn

• if used 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 • 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 product is swallowed, get medical help or contact a Poison Control Center right away.

​Directions

• Apply liberally and evenly 15 minutes before sun exposure

• Children under 6 months of age: Ask a doctor

• Reapply at least every 2 hours

• Use a water resistant sunscreen if 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 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.

​Inactive ingredients

Water, Diethylamino Hydroxybenzoyl Hexyl Benzoate, C12-15 Alkyl Benzoate, Niacinamide, Butylene Glycol, Dipropylene Glycol, Trisiloxane, Common Purslane (Portulaca Oleracea) Extract, 1,2-Hexanediol, Magnesium Aluminum Silicate, Arginine, Cetearyl Olivate, Sorbitan Olivate, Glyceryl Stearate, Cetearyl Alcohol, Chlorphenesin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Glycerin, Disodium EDTA, Scots Pine (Pinus sylvestris) Leaf Oil, Adenosine, Sodium Hyaluronate, Hydrolyzed Collagen Extract, Comfrey (Symphytum Officinale) Leaf Extract, Hydrogenated Lecithin, Diethoxyethyl Succinate, Phospholipids, Caprylic/Capric Triglyceride, Ceramide NP, Wild Mint (Mentha Arvensis) Leaf Oil, Polyglyceryl-10 Laurate, Caprylyl Glycol, Copper Tripeptide-1, Tripeptide-29, Nicotinoyl Tripeptide-1, Hexapeptide-9, Acetyl Hexapeptide-8

​Other information

• Protect the product in this container from excessive heat and direct sun.

​Questions or comments?

Call +1-213-568-3732

Monday-Friday 9 a.m.-6 p.m. Pacific Time

You may also report serious side effects to this phone number

Protects your skin from the external sun light during the day, as well as moisturizes the skin.

SUNSCREEN CREAM
BROAD SPECTRUM SPF 50

Distributed byGCOOP USA CORP. 1032 S. Crenshaw Blvd. #C-2 2ND Floor Los Angeles, CA 90019 Visit at us.gcoop.com

GB GENERAL BIO

Made in Korea

Packaging

image description

CARECELLA  DAY CREAM
avobenzone, octinoxate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69422-1302
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
NIACINAMIDE (UNII: 25X51I8RD4)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
TRISILOXANE (UNII: 9G1ZW13R0G)  
PURSLANE (UNII: M6S840WXG5)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
ARGININE (UNII: 94ZLA3W45F)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)  
ADENOSINE (UNII: K72T3FS567)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW) (UNII: 2WID9OCG7P)  
COMFREY LEAF (UNII: DG4F8T839X)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
DIETHOXYETHYL SUCCINATE (UNII: R1B8ZV94R9)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CERAMIDE NP (UNII: 4370DF050B)  
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PREZATIDE COPPER (UNII: 6BJQ43T1I9)  
ACV TRIPEPTIDE (UNII: O3VOU3H9VS)  
NICOTINURIC ACID (UNII: 77V5315PIU)  
HEXAPEPTIDE-10 (UNII: W9RS1K7T9I)  
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69422-1302-11 in 1 BOX12/19/2017
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/19/2017
Labeler - General Bio Co., Ltd. (688299527)

Revised: 12/2017
Document Id: fd8192e1-5ede-45ed-b2ec-498b125c3225
Set id: a4eb4054-ba66-41d6-897c-3ab93cad53db
Version: 2
Effective Time: 20171229
 
General Bio Co., Ltd.