SPELA VIBE CUSHION B21- titanium dioxide, octinoxate, octisalate, zinc oxide powder

SPELA VIBE CUSHION B21 by

Drug Labeling and Warnings

SPELA VIBE CUSHION B21 by is a Otc medication manufactured, distributed, or labeled by Handock Cosmetics Co., Ltd., HANACOS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Titanium Dioxide 13.94%, Ethylhexyl Methoxycinnamate 7.00%, Ethylhexyl Salicylate 5.00%, Zinc Oxide 2.88%

INACTIVE INGREDIENT

Inactive ingredients:
Purified Water, Methyl Trimethicone, Glycerin, Caprlic/CapricTriglyceride, Phenyl Trimethicone, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Lauryl PEG-10Tris(Trimethylsiloxy) Silylethyldimethicone, Isoamyl P-Methoxycinnamate, Niacinamide, Aluminum Hydroxide,
SorbitanSesquioleate, Sodium Chloride, Polyglyceryl-4 Isostearate, Stearic Acid, Cetyl PEG/PPG-10/1 Dimethicone, Yellow Oxide of Iron, Disteardimonium Hectorite, Vinyl Dimethicone/MethiconeSilsesquioxaneCrosspolymer, Phenoxyethanol, Hexyl Laurate, Triethoxycaprylylsilane, Red Oxide of Iron, Camellia Japonica Seed Oil, RubusIdaeus (Raspberry) Fruit Extract, Rosa Canina Fruit Oil, Black Oxide of Iron, Adenosine, Evening Primrose Extract, Xylitylglucoside, Butylene Clycol,Anhydroxylitol, Xylitol, 1,2-Hexanediol, HydrolyzedCollagen, Caprylyl Glycol, Kelp Extract, Enteromorpha Compressa Extract, Spirulina Platensis Extract, Seaweed Extract, Gelidium Cartilagineum Extract, Caprylhydroxamic Acid,
Tropolon

PURPOSE

Purpose: Sunscreen

WARNINGS

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 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.
- After using the product, make sure to carefully close the container cover within the refill for storage. If it is not closed, moisturizing and other effective ingredients will evaporate and contract.

DESCRIPTION

Uses:
Helps prevent sunburn. [ SPF50+ / PA+++ ]

Directions:
Apply liberally and uniformly to all exposed areas 15-20 minutes before sun exposure. Reapply often (every 2 hours) and after swimming, excessive perspiration and washing to ensure maximum sun protection.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPELA VIBE CUSHION B21 
titanium dioxide, octinoxate, octisalate, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76369-8030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.95 g  in 14 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	0.98 g  in 14 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	0.70 g  in 14 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.40 g  in 14 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Methyl Trimethicone (UNII: S73ZQI0GXM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76369-8030-2	1 in 1 CARTON	08/01/2019
1	NDC: 76369-8030-1	14 g 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	08/01/2019

Labeler - Handock Cosmetics Co., Ltd. (688037204)

Registrant - Handock Cosmetics Co., Ltd. (688037204)

Establishment
Name	Address	ID/FEI	Business Operations
HANACOS CO., LTD.		690177857	manufacture(76369-8030)