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

----------

43526-127_Deactivation

Homosalate 9.5%

Octocrylene 5.0%

Octisalate 4.5%

Avobenzone 3.0%

Sunscreen

Helps prevent sunburn

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

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

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

image description

IPKN CITY PROOF SUN MIST 
homosalate, octocrylene, octisalate, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43526-127
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE6.175 mg  in 65 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3.25 mg  in 65 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.925 mg  in 65 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.95 mg  in 65 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43526-127-021 in 1 CARTON05/02/201712/09/2020
1NDC:43526-127-0165 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/02/201712/09/2020
Labeler - Inel Cosmetics Co., Ltd. (688038939)
Registrant - Inel Cosmetics Co., Ltd. (688038939)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc689049693manufacture(43526-127)

Revised: 12/2020
Document Id: b6052115-8e19-2453-e053-2995a90a3198
Set id: 9ab3f376-54dd-46b0-8127-e98352de9c59
Version: 4
Effective Time: 20201209
 
Inel Cosmetics Co., Ltd.