THE CELLIN SC BB CREAM SPF 25 PA- titanium dioxide cream

The Cellin SC BB Cream SPF 25 PA by

Drug Labeling and Warnings

The Cellin SC BB Cream SPF 25 PA by is a Otc medication manufactured, distributed, or labeled by Cellinbio Co Ltd, KOLMAR KOREA CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Titanium Dioxide  6.39%
Octinoxate 3.00%
Zinc Oxide 1.92%

Purpose

Sunscreen

Keep out of Reach of Children

Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away.

Indication & Usage

Directions
■ Apply generously and evenly 15-20 minutes before sun exposure.
■ Use a water resistant sunscreen if swimming or sweating.
■ Reapply every 1-2 hours after towel drying, swimming or perspiring.
■ 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 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-sleeve shirts, pants, hats, and sunglasses
■ Children under 6 months: Ask a doctor

Warnings

Warnings
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging
For external use only
Do not use  on damaged or broken skin. If sun irritation develops or increases.
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash or irritation develops and lasts

Dosage & Administration

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.

Inactive Ingredient

WATER, CYCLOPENTASILOXANE, GLYCERIN, CYCLOMETHICONE, DIPROPYLENE GLYCOL, PEG-10 DIMETHICONE, TALC, HEXYLDECYL MYRISTOYL METHYLAMINOPROPIONATE, ISOPROPYL ISOSTEARATE, NIACINAMIDE, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, PORTULACA OLERACEA EXTRACT, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, C12-14 PARETH-3, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SILICA, PHENOXYETHANOL, DIMETHICONE, METHICONE, PALMITIC ACID, ALUMINUM HYDROXIDE, ALUMINUM STEARATE, ETHYLHEXYLGLYCERIN, TOCOPHERYL ACETATE, ADENOSINE, SODIUM HYALURONATE, SOLUBLE COLLAGEN, FULLERENES, HUMAN ADIPOCYTE CONDITIONED MEDIA EXTRACT, ARCTIUM LAPPA ROOT EXTRACT, PHELLINUS LINTEUS EXTRACT, BUTYLENE GLYCOL, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, DEFINED CELL CULTURE MEDIA 2, GLYCINE SOJA (SOYBEAN) SPROUT EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, PUERARIA THUNBERGIANA ROOT EXTRACT, CNIDIUM OFFICINALE ROOT EXTRACT, PAEONIA LACTIFLORA ROOT EXTRACT, ALOE BARBADENSIS LEAF JUICE, 1,2-HEXANEDIOL, GLYCERYLAMIDOETHYL METHACRYLATE/STEARYL METHACRYLATE COPOLYMER, XANTHAN GUM, CARBOMER, POLYSORBATE 20, METHYLINOSITOL, ASCORBYL HYALURONATE, PALMITOYL DIPEPTIDE-17, PALMITOYL PENTAPEPTIDE-4, CI 77492, CI 77499, CI 77491, FRAGRANCE

The Cellin SC BB Cream SPF25 PA

The Cellin SC BB Cream SPF25 PA
Net WT. 1.01 FL OZ (30ml)

INGREDIENTS AND APPEARANCE

THE CELLIN SC BB CREAM SPF 25 PA  
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76173-1100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6.39 g  in 30 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.00 g  in 30 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.92 g  in 30 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
TALC (UNII: 7SEV7J4R1U)
HEXYLDECYL MYRISTOYL METHYLAMINOPROPIONATE (UNII: 1959TW0O9A)
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
NIACINAMIDE (UNII: 25X51I8RD4)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MAGNESIUM SULFATE (UNII: DE08037SAB)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PURSLANE (UNII: M6S840WXG5)
C12-14 PARETH-3 (UNII: 93RY22U87E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHICONE (20 CST) (UNII: 6777U11MKT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PALMITIC ACID (UNII: 2V16EO95H1)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ADENOSINE (UNII: K72T3FS567)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUCKMINSTERFULLERENE (UNII: NP9U26B839)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
CHAMOMILE (UNII: FGL3685T2X)
SOYBEAN (UNII: L7HT8F1ZOD)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)
CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
METHYLINOSITOL (UNII: TF9HZN9T0M)
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)

Product Characteristics
Color	white (black)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76173-1100-2	1 in 1 BOX
1	NDC: 76173-1100-1	30 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/28/2013

Labeler - Cellinbio Co Ltd (557803737)

Registrant - Cellinbio Co Ltd (557803737)

Establishment
Name	Address	ID/FEI	Business Operations
Cellinbio Co Ltd		557803737	relabel(76173-1100)

Establishment
Name	Address	ID/FEI	Business Operations
KOLMAR KOREA CO LTD		687846360	manufacture(76173-1100)