SECRET NATURE CALENDULA PRIMER SUNSCREEN- octocrylene, octinoxate, octisalate stick 
HANKOOK COSMETICS MANUFACTURING 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 ingredients

Active ingredients: Octocrylene 8.0%, Ethylhexyl Methoxycinnamate 7.0%, Ethylhexyl Salicylate 5.0%

INACTIVE INGREDIENT

Inactive ingredients:

Dimethicone, Triethylhexanoin, Ceresin, Silica, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Ozokerite, Phenyl Trimethicone, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Euphorbia Cerifera (Candelilla) Wax, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Methyl Methacrylate Crosspolymer, Microcrystalline Wax, Sorbitan Caprylate, Sorbitan Sesquioleate, Caprylyl Glycol, Citrus Aurantium Dulcis (Orange) Peel Oil, Pelargonium Graveolens Flower Oil, Caprylic/Capric Triglyceride, Calendula Officinalis Flower Extract, Water, Butylene Glycol, 1,2-Hexanediol, Opuntia Coccinellifera Fruit Extract, Camellia Japonica Leaf Extract, Citrus Unshiu Peel Extract, Orchid Extract, Camellia Sinensis Leaf Extract, Chaenomeles Sinensis Fruit Extract, Melissa Officinalis Extract, Citrus Aurantium Dulcis (Orange) Flower Extract

Purpose

Purpose: Sunscreen

Warnings

Warnings:

1. Stop using if the following reactions occur at the contact area. Continuous use can worsen the reactions, so consult a dermatologist. If red spots, swelling, itchiness or irritations occur. If the above are observed in the area of application as a result of exposure to direct sunlight. 2. Do not apply if there is scratch, eczema or dermatitis on the skin. 3. Storage and Handling 1) Keep out of reach of children. 2) Keep out of high and low temperature and avoid exposure to direct sunlight.

DESCRIPTION

Uses:

- A primer sunscreen stick that instantly smoothes the skin surface by minimizing the appearance of pores and fine lines and strongly protects the skin from the sun

- Helps prevent sunburn

Directions:

- Before base makeup, apply liberally and evenly on the skin, concentrating on areas where you have pores and fine lines, For effective sun protection, reapply frequently.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

SECRET NATURE CALENDULA PRIMER SUNSCREEN 
octocrylene, octinoxate, octisalate stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58544-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene1.6 g  in 20 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate1.4 g  in 20 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate1.0 g  in 20 g
Inactive Ingredients
Ingredient NameStrength
Dimethicone (UNII: 92RU3N3Y1O)  
Triethylhexanoin (UNII: 7K3W1BIU6K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58544-103-021 in 1 CARTON02/01/201810/30/2018
1NDC:58544-103-0120 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/201810/30/2018
Labeler - HANKOOK COSMETICS MANUFACTURING CO.,LTD. (687772475)
Registrant - Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory (688235645)
Establishment
NameAddressID/FEIBusiness Operations
Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory688235645manufacture(58544-103)

Revised: 11/2018
 
HANKOOK COSMETICS MANUFACTURING CO.,LTD.