SKINFOOD MIRACLE FOOD 10 SOLU TION SUN ESSENCE by SKINFOOD CO.,LTD. / IPEERES COSMETICS CO., LTD.

SKINFOOD MIRACLE FOOD 10 SOLU TION SUN ESSENCE by

Drug Labeling and Warnings

SKINFOOD MIRACLE FOOD 10 SOLU TION SUN ESSENCE 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 MIRACLE FOOD 10 SOLU TION SUN ESSENCE- octinoxate, octisalate, ensulizole, titanium dioxide, zinc oxide, avobenzone 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.

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ACTIVE INGREDIENT

Active Ingredients: OCTYL METHOXYCINNAMATE 7.00%, OCTYL SALICYLATE 5.00%, PHENYLBENZIMIDAZOLE SULFONIC ACID 3.00%, TITANIUM DIOXIDE 1.58%, ZINC OXIDE 1.42%, AVOBENZONE 1.2%

INACTIVE INGREDIENT

Inactive Ingredients: WATER, NIACINAMIDE, DIPROPYLENE GLYCOL, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, CETEARYL ALCOHOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, SORBITAN STEARATE, GLYCERYL STEARATE, PEG-100 STEARATE, CETEARYL OLIVATE, SODIUM HYDROXIDE, SORBITAN OLIVATE, DIMETHICONE, ETHYLHEXYLGLYCERIN, POLYACRYLATE-13, PEG-10 DIMETHICONE, LACTOBACILLUS/ASPERGILLUS/PRUNUS MUME FRUIT FERMENT FILTRATE, POLYISOBUTENE, DISODIUM EDTA, PORTULACA OLERACEA EXTRACT, TOCOPHERYL ACETATE, DIMETHICONE/METHICONE COPOLYMER, FOMES OFFICINALIS (MUSHROOM) EXTRACT, ADENOSINE, TRIETHOXYCAPRYLYLSILANE, POLYSORBATE 20, SORBITAN ISOSTEARATE, DAUCUS CAROTA SATIVA (CARROT) ROOT EXTRACT, GLYCERIN, PANAX GINSENG ROOT EXTRACT, CANOLA OIL, TOCOPHEROL, RUBUS COREANUS FRUIT EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, MELISSA OFFICINALIS LEAF EXTRACT, ARTEMISIA VULGARIS EXTRACT, PENTYLENE GLYCOL, SPINACIA OLERACEA (SPINACH) LEAF EXTRACT, ARISTOTELIA CHILENSIS FRUIT EXTRACT, CHENOPODIUM QUINOA EXTRACT, YEAST EXTRACT, POLYGLYCERYL-3 POLYRICINOLEATE, 1,2-HEXANEDIOL, CAPRYLYL GLYCOL, PALMITIC ACID, HONEY EXTRACT, GANODERMA LUCIDUM (MUSHROOM) EXTRACT, STEARIC ACID, ASCORBIC ACID, CARBOMER, POLYSORBATE 80, ACETYL HEXAPEPTIDE-8, SODIUM CARBOMER, TRIPEPTIDE-29, PALMITOYL TRIPEPTIDE-1, PALMITOYL TETRAPEPTIDE-7, PHENOXYETHANOL, FRAGRANCE

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 medical help 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

Image of bottleImage of bottle

SKINFOOD MIRACLE FOOD 10 SOLU TION SUN ESSENCE 
octinoxate, octisalate, ensulizole, titanium dioxide, zinc oxide, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 76214-063
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.5 g  in 50 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE1.5 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.7 g  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.7 g  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.6 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
NIACINAMIDE (UNII: 25X51I8RD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 76214-063-0150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/201611/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/201611/01/2019
Labeler - SKINFOOD CO.,LTD. (690324173)
Registrant - SKINFOOD CO.,LTD. (690324173)
Establishment
NameAddressID/FEIBusiness Operations
IPEERES COSMETICS CO., LTD.687590526manufacture(76214-063)

Revised: 12/2019
 

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