OTC Medication Information: INCELLDERM Cocktail Aqua Sun

INCELLDERM COCKTAIL AQUA SUN- octinoxate, octisalate, homosalate and titanium dioxide gel
Riman 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 INGREDIENT

Active ingredients:

Ethylhexyl Methoxycinnamate 7.00%, Ethylhexyl Salicylate 3.00%, Homosalate 3.00%, Titanium Dioxide 1.49%

INACTIVE INGREDIENT

Inactive ingredients:


Aloe Barbadensis Leaf Juice, Butylene Glycol, Ethyl Hexanediol, 1,2-Hexanediol, Niacinamide, Pentylene Glycol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Aluminum Hydroxide, Stearic Acid, Caprylyl Methicone, Glycerin, Ethylhexy Triazone, Isononyl Isononanoate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Sorbitan Oleate, Water, Water, Sodium Hyaluronate, 1,2-Hexanediol, 1,2-Hexanediol, Cyclopentasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Ammonium Acryloyldimethyltaurate/VP Copolymer, Allantoin, Tocopheryl Acetate, Citrus Aurantium Dulcis (Orange) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Pelargonium Graveolens Flower Oil, Amyris Balsamifera Bark Oil, Citrus Grandis (Grapefruit) Peel Oil, Eucalyptus Globulus Leaf Oil, Mentha Arvensis Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Juniperus Mexicana Oil, Boswellia Carterii Oil, Sorbitan Isostearate, Ethylhexylglycerin, Adenosine, Xanthan Gum, Glycerin, Water, Pancratium Maritimum Extract, Water, Butylene Glycol, Sophora Japonica Fruit Extract, Ethyl Hexanediol, 1,2-Hexanediol, Water, Butylene Glycol, Althaea Rosea Flower Extract, Aloe Barbadensis Leaf Extract, Phenoxyethanol, Ethylhexylglycerin, Polyglyceryl-3 Methylglucose Distearate

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:


1. Consult a physician if red spots, swollenness, itchiness, or any other adnormal symptoms or side effects develops on the applied area during or after use or under direct sunlight.
2. Do not use on wound, etc.
3. Precautions for handling and storage
a) Keep out of the reach of children
b) Avoid direct sunlight

DESCRIPTION

Uses:
Protects skin from UV rays (SPF50 + / PA +++)

Directions:
After gently shaking it up and down, apply to the skin or mix with the cocktail BB and apply to the whole face. Apply this product once every 2 hours.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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INCELLDERM COCKTAIL AQUA SUN
octinoxate, octisalate, homosalate, titanium dioxide gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72650-060
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (OCTINOXATE) Octinoxate 3.50 g in 50 mL
Octisalate (OCTISALATE) Octisalate 1.50 g in 50 mL
Homosalate (HOMOSALATE) Homosalate 1.50 g in 50 mL
Titanium Dioxide (TITANIUM DIOXIDE) Titanium Dioxide 0.74 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
Butylene Glycol
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72650-060-02 1 CONTAINER in 1 CARTON contains a CONTAINER (72650-060-01)
1 NDC:72650-060-01 50 mL in 1 CONTAINER This package is contained within the CARTON (72650-060-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 03/01/2019
Labeler — Riman Co., Ltd. (694893735)
Registrant — Riman Co., Ltd. (694893735)
Establishment
Name Address ID/FEI Operations
HANSOLBIOTECH 694455165 manufacture (72650-060)

Revised: 04/2019 Riman 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.

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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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