Drug Details [pdf]

AAPE CONTINUOUS RENEWAL SUN- octinoxate, zinc oxide cream
PROSTEMICS 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.

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ACTIVE INGREDIENT

Active Ingredient: ETHYLHEXYL METHOXYCINNAMATE 7.5%, ZINC OXIDE 2.8%

INACTIVE INGREDIENT

Inactive Ingredient:
WATER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, SODIUM HYALURONATE, ISOAMYL p-METHOXYCINNAMATE, DICAPRYLYL CARBONATE, DIMETHICONE CROSSPOLYMER, SORBITAN ISOSTEARATE, BETULA PLATYPHYLLA JAPONICA JUICE, ARNICA MONTANA FLOWER EXTRACT, ARTEMISIA ABSINTHIUM EXTRACT, ACHILLEA MILLEFOLIUM EXTRACT, GENTIANA LUTEA ROOT EXTRACT, ALCOHOL, ISODODECANE, TITANIUM DIOXIDE, ALUMINUM HYDROXIDE, STEARIC ACID, HUMAN ADIPOCYTE CONDITIONED MEDIA EXTRACT, GLYCERYL CITRATE, LACTATE, LINOLEATE, OLEATE, OLIVE OIL, POLYSORBATE60, 1,2-HEXANEDIOL, TROPOLONE, PROPYLENE GLYCOL, BETA-GLUCAN, PORTULACA OLERACEA EXTRACT, CAPRYLYL GLYOCOL, ETHYLHEXYLGLYCERIN, SODIUM CHLORIDE, OZOKERITE, CETYL PEG/PPG-10/1 DIMETHICONE, TOCOPHERYL ACETATE, SILICA, DISODIUM EDTA, FRAGRANCE

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:
1. In case of having following symptoms after using this product, stop using it immediately. If the symptoms get worse, you need to consult a dermatologist.
1) In case of having problems such as red spots, swelling, itching or irritation during using this product,
2) In case of having the same symptoms above on the part where you put this product, which is exposed to direct sunlight.
2. Do not use it on the part where you have a scar, eczema or dermatitis.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children:
Keep out of infants or children's reach.

INDICATIONS & USAGE

Indication and Usage:
1. Always keep a tight lid after use.
2. Do not put it in extremely hot or cold places or where exposed to direct sunlight.

DOSAGE & ADMINISTRATION

Dosage and Administration:
Always at the final step in your skin-care routine, apply a table spoon of sun cream each morning to face and neck. Use more every couple hours.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

AAPE CONTINUOUS RENEWAL SUN
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62041-030
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4.50 mg in 60 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1.68 mg in 60 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 62041-030-01	60 mL in 1 CARTON; Type 0: Not a Combination Product	11/01/2014	03/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/01/2014	03/01/2019

Labeler - PROSTEMICS Co., Ltd. (689605919)

Registrant - PROSTEMICS Co., Ltd. (689605919)

Name	Address	ID/FEI	Business Operations
Establishment
PROSTEMICS Co., Ltd.		689605919	manufacture(62041-030)

Revised: 5/2019

Document Id: 88a9568b-f40f-49a7-b713-43ae096d0620

Set id: 447dfdfd-298d-4014-a508-7bcff0abe0ce

Version: 4

Effective Time: 20190530

Drug Labeling and Warnings