OTC Medication Information: BROCCOLI SUN SPF42 PA PLUS PLUS PLUS

BROCCOLI SUN SPF42 PA PLUS PLUS PLUS- octinoxate, octisalate, zinc oxide and titanium dioxide cream
SKINFOOD CO., LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredients: OCTINOXATE 5%, OCTISALATE 5%, ZINC OXIDE 3.8%, TITANIUM DIOXIDE 2.87%

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: Protects skin from UV rays.

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.

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

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 2.5 mL in 50 mL
OCTISALATE (OCTISALATE) OCTISALATE 2.5 mL in 50 mL
ZINC OXIDE (ZINC CATION) ZINC OXIDE 1.9 mL in 50 mL
TITANIUM DIOXIDE (TITANIUM) TITANIUM DIOXIDE 1.44 mL in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CYCLOMETHICONE 5
ALKYL (C12-15) BENZOATE
BEMOTRIZINOL
DIETHYLHEXYL CARBONATE
CETYL OCTANOATE
DIMETHICONE
CYCLOMETHICONE 6
PEG-30 DIPOLYHYDROXYSTEARATE
SODIUM CHLORIDE
PROPYLENE CARBONATE
POLYGLYCERYL-4 ISOSTEARATE
SORBITAN SESQUIOLEATE
HEXYL LAURATE
SORBITAN OLIVATE
TRIMETHOXYCAPRYLYLSILANE
METHYLPARABEN
ALOE VERA LEAF
BROCCOLI
BUTYLENE GLYCOL
BUTYLPARABEN
MATRICARIA RECUTITA
PURSLANE
PROPYLENE GLYCOL
EDETATE DISODIUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76214-018-01 50 mL in 1 BOTTLE None
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 Operations
SKINFOOD CO., LTD. 690324173 manufacture

Revised: 09/2011 SKINFOOD CO., LTD.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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