OTC Medication Information: ALOE SUN SPF28 PA PLUS PLUS

ALOE SUN SPF28 PA PLUS PLUS- octinoxate and ensulizole spray
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 7%, ENSULIZOLE 2%

Inactive ingredients:
WATER, C12-15 ALKYL BENZOATE, 4-METHYLBENZYLIDENE CAMPHOR, BUTYLENE GLYCOL, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETEARETH-6 OLIVATE, PEG-7 GLYCERYL COCOATE, ALOE BARBADENSIS LEAF EXTRACT, C12-20 ALKYL GLUCOSIDE, C14-22 ALCOHOLS, DIMETHICONE, MALPIGHIA GLABRA(ACEROLA) FRUIT EXTRACT, GLYCERIN, SODIUM HYDROXIDE, CELLULOSE GUM, CETEARYL OLIVATE, SORBITAN OLIVATE, MICROCRYSTALLINE CELLULOSE, DISODIUM EDTA, ETHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, METHYLPARABEN, PROPYLPARABEN, 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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ALOE SUN SPF28 PA PLUS PLUS
octinoxate spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76214-019
Route of Administration CUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 7 mL in 100 mL
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE 2 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ENZACAMENE
ALKYL (C12-15) BENZOATE
BUTYLENE GLYCOL
BEMOTRIZINOL
MEDIUM-CHAIN TRIGLYCERIDES
ALOE VERA LEAF
C12-20 ALKYL GLUCOSIDE
C14-22 ALCOHOLS
DIMETHICONE
GLYCERIN
METHYLPARABEN
SODIUM HYDROXIDE
CARBOXYMETHYLCELLULOSE SODIUM
CETEARYL OLIVATE
SORBITAN OLIVATE
PROPYLPARABEN
EDETATE DISODIUM
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76214-019-01 100 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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