CARECELLA DAY CREAM- avobenzone, octinoxate, octocrylene cream

CareCella by

Drug Labeling and Warnings

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

Drug Details [pdf]

​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

​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

SPL UNCLASSIFIED SECTION

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

SUNSCREEN CREAM
BROAD SPECTRUM SPF 50

Distributed by​ GCOOP 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

INGREDIENTS AND APPEARANCE

CARECELLA  DAY CREAM
avobenzone, octinoxate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69422-1302
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69422-1302-1	1 in 1 BOX	12/19/2017
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
OTC monograph not final	part352	12/19/2017

Labeler - General Bio Co., Ltd. (688299527)