CARROT SUN SPF30 PA PLUS PLUS- octinoxate cream

CARROT SUN by

Drug Labeling and Warnings

CARROT SUN by is a Otc medication manufactured, distributed, or labeled by SKINFOOD CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: OCTINOXATE 6%, OCTISALATE 5%, TITANIUM DIOXIDE 3.4%, AVOBENZONE 1.5%

INACTIVE INGREDIENT

Inactive ingredients:
WATER, PROPYLENE GLYCOL, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, ISOAMYL p-METHOXYCINNAMATE, ISOPROPYL MYRISTATE, CETYL ALCOHOL, POLYSORBATE 80, DIETHYLHEXYL CARBONATE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, POTASSIUM CETYL PHOSPHATE, GLYCERYL STEARATE, PEG-100 STEARATE, POLYGLYCERYL-6 POLYHYDROXYSTEARATE, CAPRYLYL GLYCOL, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ISOHEXADECANE, ALUMINUM HYDROXIDE, STEARIC ACID, BAMBUSA TEXTILIS STEM EXTRACT, BETA-GLUCAN, CITRUS GRANDIS (GRAPEFRUIT) SEED EXTRACT, GLYCERIN, PINUS PALUSTRIS LEAF EXTRACT, TRIDECETH-6, ETHYLHEXYL STEARATE, SODIUM POLYACRYLATE, DAUCUS CAROTA SATIVA (CARROT) ROOT EXTRACT, TRIMETHOXYCAPRYLYLSILANE, BHT, DISODIUM EDTA, TOCOPHERYL ACETATE, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER OIL, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, CITRUS AURANTIUM DULCIS (ORANGE) OIL, CITRUS MEDICA LIMONUM (LEMON) FRUIT OIL, FOENICULUM VULGARE (FENNEL) OIL, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, ZEA MAYS (CORN) OIL

PURPOSE

Purpose: Protects skin from UV rays.

WARNINGS

Warnings:
For external use only. Avoid contact with eyes.
Discontinue use if signs of irritation appear.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children:
Keep out of reach of children.

INDICATIONS & USAGE

Indication and usage:
After your daily skincare regimen, apply liberally onto your face, neck, arms, legs, and other areas that are easily exposed to UV sunlight. Avoid the eye area.

DOSAGE & ADMINISTRATION

Dosage and administration:
For best results, apply at least 15 to 20 minutes before sun exposure.
Reapply frequently while out in the sun.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CARROT SUN  SPF30 PA PLUS PLUS
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76214-014
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3 g  in 50 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.5 g  in 50 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE)	TITANIUM DIOXIDE	1.7 g  in 50 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.75 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ISOHEXADECANE (UNII: 918X1OUF1E)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERIN (UNII: PDC6A3C0OX)
PINUS PALUSTRIS POLLEN (UNII: E3A7U1HWIO)
CARROT (UNII: L56Z1JK48B)
TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
BERGAMOT OIL (UNII: 39W1PKE3JI)
CITRUS SINENSIS FLOWER OIL (UNII: AJ56JP5TFP)
CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)
FENNEL OIL (UNII: 59AAO5F6HT)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ROSEMARY OIL (UNII: 8LGU7VM393)
STARCH, CORN (UNII: O8232NY3SJ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76214-014-01	50 g in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/01/2011

Labeler - SKINFOOD CO., LTD. (690324173)

Registrant - SKINFOOD CO., LTD. (690324173)

Establishment
Name	Address	ID/FEI	Business Operations
SKINFOOD CO., LTD.		690324173	manufacture