IPKN CITY PROOF SUN MIST- homosalate, octocrylene, octisalate, avobenzone cream

IPKN CITY PROOF SUN MIST by

Drug Labeling and Warnings

IPKN CITY PROOF SUN MIST by is a Otc medication manufactured, distributed, or labeled by Inel Cosmetics Co., Ltd., Cosmax, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Homosalate 9.5%

Octocrylene 5.0%

Octisalate 4.5%

Avobenzone 3.0%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure.

Reapply at least every two 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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
Ask a doctor to use for children under 6 months

WARNINGS

For external use only.
Do not use on damaged or broken skin.
When using this product, keep out of eyes. Rinse with water to remove.
Stop using and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

INACTIVE INGREDIENT

Water
Butylene Glycol
Alcohol Denat.
Phenethyl Benzoate
Triceteareth-4 Phosphate
Glycol Stearate
Hydrolyzed Wheat Protein/PVP Crosspolymer
PEG-2 Stearate
Phenoxyethanol
Hydroxyacetophenone
Caprylyl Glycol
Glyceryl Caprylate
Disodium EDTA
Potassium Sorbate
Water
Aloe Barbadensis Leaf Juice
Ethylhexylglycerin
Althaea Rosea Flower Extract
Algae Extract (Retired)
Carthamus Tinctorius (Safflower) Flower Extract
Chlorella Vulgaris Extract
Plantago Asiatica Extract
Portulaca Oleracea Extract
Punica Granatum Fruit Extract
Mesembryanthemum Crystallinum Extract
Brassica Napus Extract
Brassica Oleracea Gongylodes Extract
Chenopodium Quinoa Extract
Ocimum Basilicum (Basil) Leaf Extract
Pisum Sativum (Pea) Extract
Camellia Sinensis Leaf Extract
Angelica Dahurica Root Extract
Castanea Sativa (Chestnut) Leaf Extract
Morus Alba Root Extract
Paeonia Albiflora Root Extract
Polygonatum Officinale Rhizome/Root Extract
Polygonum Multiflorum Root Extract
Poria Cocos Extract
Silkworm Extract
Pyrus Malus (Apple) Fruit Extract
Rosmarinus Officinalis (Rosemary) Leaf Extract
1,2-Hexanediol
Mentha Piperita (Peppermint) Extract
Cymbopogon Schoenanthus Extract
Lavandula Angustifolia (Lavender) Flower Extract
Sodium Benzoate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IPKN CITY PROOF SUN MIST 
homosalate, octocrylene, octisalate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43526-127
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6.175 mg  in 65 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3.25 mg  in 65 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.925 mg  in 65 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.95 mg  in 65 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
PHENETHYL BENZOATE (UNII: 0C143929GK)
TRICETEARETH-4 PHOSPHATE (UNII: 69534Y66NO)
GLYCOL STEARATE (UNII: 0324G66D0E)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)
PEG-2 STEARATE (UNII: 94YQ11Y95F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
2-HYDROXYACETOPHENONE (UNII: DQ1N9R01IA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALCEA ROSEA FLOWER (UNII: 1250O8MKPZ)
SAFFLOWER (UNII: 4VBL71TY4Y)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
PLANTAGO ASIATICA (UNII: 5F5728J5E8)
PURSLANE (UNII: M6S840WXG5)
POMEGRANATE (UNII: 56687D1Z4D)
BRASSICA NAPUS SUBSP. NAPUS (UNII: NFP6814VZ4)
BASIL (UNII: 2U0KZP0FDW)
PEA (UNII: W4X7H8GYFM)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)
CASTANEA SATIVA LEAF (UNII: IV3S2HH53G)
MORUS ALBA ROOT (UNII: CST1G9BZGD)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
POLYGONATUM ODORATUM ROOT (UNII: KPF03O64AZ)
REYNOUTRIA MULTIFLORA ROOT (UNII: AUZ3VD75MC)
APPLE (UNII: B423VGH5S9)
ROSEMARY (UNII: IJ67X351P9)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
MENTHA PIPERITA (UNII: 79M2M2UDA9)
CYMBOPOGON SCHOENANTHUS TOP (UNII: 9SJI1LW39W)
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43526-127-02	1 in 1 CARTON	05/02/2017
1	NDC: 43526-127-01	65 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/02/2017

Labeler - Inel Cosmetics Co., Ltd. (688038939)

Registrant - Inel Cosmetics Co., Ltd. (688038939)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc		689049693	manufacture(43526-127)