BROCCOLI SUN SPF42 PA PLUS PLUS PLUS- octinoxate cream

BROCCOLI SUN by

Drug Labeling and Warnings

BROCCOLI 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 5%, OCTISALATE 5%, ZINC OXIDE 3.8%, TITANIUM DIOXIDE 2.87%

INACTIVE INGREDIENT

Inactive ingredients:
WATER, CYCLOPENTASILOXANE, C12-15 ALKYL BENZOATE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, DIETHYLHEXYL CARBONATE, ISOAMYL p-METHOXYCINNAMATE, CETYL CAPRYLATE, DIMETHICONE, CYCLOHEXASILOXANE, CETYL PEG/PPG-10/1 DIMETHICONE, STEARALKONIUM HECTORITE, POLYGLYCERYL-6 POLYHYDROXYSTEARATE,
PEG-30 DIPOLYHYDROXYSTEARATE, SODIUM CHLORIDE, PEG-10 DIMETHICONE, OZOKERITE, PROPYLENE CARBONATE, POLYGLYCERYL-4 ISOSTEARATE, SORBITAN SESQUIOLEATE, ALCOHOL DENAT., HEXYL LAURATE, SORBITAN OLIVATE, TRIMETHOXYCAPRYLYLSILANE, DIMETHICONE, ALOE BARBADENSIS LEAF EXTRACT, BRASSICA OLERACEA ITALICA (BROCCOLI) EXTRACT, BUTYLENE GLYCOL, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, PORTULACA OLERACEA EXTRACT, PROPYLENE GLYCOL, DISODIUM EDTA, METHYLPARABEN, BUTYLPARABEN, FRAGRANCE

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: Use at the end of your daily skincare regimen. Apply liberally onto face and body before sun exposure avoiding 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

BROCCOLI SUN  SPF42 PA PLUS PLUS PLUS
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76214-018
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.5 mL  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.5 mL  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC OXIDE	1.9 mL  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE)	TITANIUM DIOXIDE	1.44 mL  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BEMOTRIZINOL (UNII: PWZ1720CBH)
DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)
CETYL OCTANOATE (UNII: 418Q5V6PLJ)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
SORBITAN OLIVATE (UNII: MDL271E3GR)
TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)
METHYLPARABEN (UNII: A2I8C7HI9T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BROCCOLI (UNII: UOI4FT57BZ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)
PURSLANE (UNII: M6S840WXG5)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76214-018-01	50 mL in 1 BOTTLE

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