PLAGENTRA BABY SUNCITY- octinoxate, octisalate, titanium dioxide cream

PLAGENTRA BABY SUNCITY by

Drug Labeling and Warnings

PLAGENTRA BABY SUNCITY by is a Otc medication manufactured, distributed, or labeled by C.A Pharm Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: ETHYLHEXYL METHOXYCINNAMATE 7.5%, ETHYLHEXYL SALICYLATE 5.0%, TITANIUM DIOXIDE 3.0%

INACTIVE INGREDIENT

Inactive Ingredients:
Water, Cyclopentasiloxane, Isohexadecane, Butylene Glycol, Isoamyl p-Methoxycinnamate, Glycerin, Polysorbate 60, C12-15 Alkyl Benzoate, Dimethicone, Glyceryl Stearate, Dimethicone Crosspolymer, Sorbitan Stearate, Stearic Acid, VP/Eicosene Copolymer, PEG-100 Stearate, Cetearyl Alcohol, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polysorbate 80, PEG-10 Dimethicone, Hexyl Laurate, Panthenol, Caprylyl glycol, Fragrance, Ethylhexylglycerin, Tropolone, Tocopheryl Acetate, Alumina, Magnesium Aluminum Silicate, Polyglutamic Acid, Leuconostoc/Radish Root Ferment Filtrate, Arnica Montana Flower Extract, Achillea Millefolium Extract, Gentiana Lutea Root Extract, Artemisia Absinthium Extract, Xanthan Gum, Disodium EDTA, Sodium Hyaluronate, Ethyl Ascorbyl Ether, Human Oligopeptide-1, Oligopeptide-3

PURPOSE

Purpose: UVA/UVB Protection

WARNINGS

Warnings:
1. Stop using the product and go to a doctor immediately if one of the following symptoms occurs. If immediate care is not sought, the symptoms may worsen :
1) Itching, redness, swelling, rash, etc. 2) If one of the symptoms above occurs due to direct sunlight.
2. Do not apply the product to wounds or skin with dermatitis such as eczema.
3. Storage and Handling, 1) Keep the lid closed after use. 2) Keep the product out of children's reach. 3) Keep away from direct sunlight, do not store at high or low temperature.
4. It contains AHA. If it is your first time to use this product, take a small amount and gently apply to the skin to check if it cause andy trouble to your skin.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of babies and children.

INDICATIONS & USAGE

Indication and usage:
1) Tighten the lid after using it.
2) Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight.
3) Use it on the day you will be in the sun, 30 minutes before you go outside, apply an ounce of sunscreen.

DOSAGE & ADMINISTRATION

Dosage and administration:
To apply sunscreen, squeeze a dollop of sun cream onto your hand and rub it all the skin that will be exposed to UV.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PLAGENTRA BABY SUNCITY 
octinoxate, octisalate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68988-090
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4.5 g  in 60 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 60 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.8 g  in 60 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68988-090-01	60 g in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2014

Labeler - C.A Pharm Co., Ltd. (688198385)

Registrant - C.A Pharm Co., Ltd. (688198385)

Establishment
Name	Address	ID/FEI	Business Operations
C.A Pharm Co., Ltd.		688198385	manufacture(68988-090)