SKINFOOD ROYAL HONEY GOOD SUN by SKINFOOD CO.,LTD. / IPEERES COSMETICS CO., LTD.

SKINFOOD ROYAL HONEY GOOD SUN by

Drug Labeling and Warnings

SKINFOOD ROYAL HONEY GOOD SUN by is a Otc medication manufactured, distributed, or labeled by SKINFOOD CO.,LTD., IPEERES COSMETICS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SKINFOOD ROYAL HONEY GOOD SUN- octinoxate, octisalate, titanium dioxide gel 
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.

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ACTIVE INGREDIENT

Active Ingredients: OCTYL METHOXYCINNAMATE 7.00%, OCTYL SALICYLATE 5.00%, TITANIUM DIOXIDE 0.93%

INACTIVE INGREDIENT

Inactive Ingredients: WATER, GLYCERIN, ISOAMYL p-METHOXYCINNAMATE, CYCLOPENTASILOXANE, CETEARETH-6 OLIVATE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, C14-22 ALCOHOLS, HONEY EXTRACT, ALCOHOL DENAT., POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, POLYSORBATE 80, GLYCERYL STEARATE, ROYAL JELLY EXTRACT, BETA-GLUCAN, BUTYLENE GLYCOL, SORBITAN STEARATE, SILICA, PEG-100 STEARATE, C12-20 ALKYL GLUCOSIDE, DIPROPYLENE GLYCOL, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER, ISOHEXADECANE, POTASSIUM CETYL PHOSPHATE, PORTULACA OLERACEA EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, ALUMINUM HYDROXIDE, STEARIC ACID, DISODIUM EDTA, SORBITAN OLEATE, DIPTERYX ODORATA BEAN EXTRACT, GLUCOSE, 1,2-HEXANEDIOL, ETHYLHEXYLGLYCERIN, PHENOXYETHANOL

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medicalhelp or contact a Poison Control Center right away.

DESCRIPTION

Use: Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Directions: Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months of age: Ask a doctor.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SKINFOOD ROYAL HONEY GOOD SUN 
octinoxate, octisalate, titanium dioxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76214-062
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.5 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.5 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.4 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76214-062-01	50 mL in 1 TUBE; Type 0: Not a Combination Product	08/01/2016	11/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/01/2016	11/01/2019

Labeler - SKINFOOD CO.,LTD. (690324173)

Registrant - SKINFOOD CO.,LTD. (690324173)

Establishment
Name	Address	ID/FEI	Business Operations
IPEERES COSMETICS CO., LTD.		687590526	manufacture(76214-062)

Revised: 12/2019

Document Id: 0485e6fe-3d72-4ce2-bc05-81507bdfaa90

34390-5

Set id: c7af2d57-87c7-40d2-b794-477d6d86a250

Version: 2

Effective Time: 20191226