TONE UP WHITE SUN

Manufacturer
WOW VENTURES | Cosmecca Korea Co.,Ltd.
Effective date
2015-06-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:42:51

Label at a glance#

ProductTONE UP WHITE SUN
Active ingredientZinc Oxide, Titanium Dioxide, Octinoxate, Octisalate
Label structure6 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Zinc Oxide 7.20%, Titanium Dioxide 4.15%, Ethylhexyl Methoxycinnamate 4.00%, Ethylhexyl Salicylate 4.00%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Chamaecyparis Obtusa Water, Cyclopentasiloxane, Silica, Caprylic/Capric Triglyceride, Butylene Glycol, Alcohol Denat., PEG-10 Methyl Ether Dimethicone, Isopropyl Palmitate, C12-15 Alkyl Benzoate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Caprylyl Methicone, Dipropylene Glycol, Niacinamide, Sodium Chloride, Quaternium-18 Bentonite, PEG-10 Dimethicone, Stearalkonium Hectorite, Aluminum Hydroxide, Sorbitan Sesquioleate, Sorbitan Olivate, Stearic Acid, Polyhydroxystearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Phenoxyethanol, Dimethicone, Hydrogen Dimethicone, Fragrance, Water, Propylene Carbonate, Ethylhexyl Palmitate, Lecithin, Tocopheryl Acetate, Isostearic Acid, Sodium Benzoate, Polyglyceryl-3 Polyricinoleate, Disodium EDTA, Potassium sorbate, Adenosine, Prunus armeniaca (apricot) fruit extract, Melaleuca Alternifolia (Tea Tree) Leaf Water, Citrus Limon (Lemon) Fruit Extract, Portulaca Oleracea Extract, Pyrus Malus (Apple) Fruit Extract, Citrus aurantium dulcis (orange) fruit extract, Centella Asiatica Extract, Pentylene Glycol, Caprylyl Glycol, 1,2-Hexanediol, Ethylhexylglycerin

PURPOSE

OTC - PURPOSE SECTION

Purpose: Sunscreen

WARNINGS

WARNINGS SECTION

Warnings: 1. If any of the following symptoms appear on the area where the product was applied, stop using the product immediately and consult a specialist. A. Redness, swelling, itchiness, irritation or other abnormal symptoms B. Symptoms above appear after exposure to direct sunlight 2. Do NOT use the product on an area with wound, eczema, or dermatitis 3. Storage and handling. A. Make sure to close the lid after use B. Keep away from children and babies C. Do NOT store in a place with high or low temperature and direct sunlight

DESCRIPTION

DESCRIPTION SECTION

Directions & Usage: Apply liberally on face and body 15 minutes before sun exposure.

Dosage & Administration: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69894-310-012020-01-31C16284748780-19d75b9d0-4666-f424-e053-dadaa90a57ce85759f43-2903-48ff-939e-46f9661a1613

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69894-310-01TONE UP WHITE SUN50 mL in 1 CARTONCREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69894-310TONE UP WHITE SUN (ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE) CREAM [WOW VENTURES]1Legacy NDC, 1 package rows20150626_85759f43-2903-48ff-939e-46f9661a1613.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD511
OctisalateACTIVE INGREDIENT4X49Y0596W1
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP1
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
ZINC CATIONACTIVE MOIETY13S1S8SF371
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RA1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69894-31069894-310-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Butylene GlycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates
Butylene GlycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a61342ff-6a0f-4604-8e4c-143a8d57431385759f43-2903-48ff-939e-46f9661a16132015-06-26WarningsExact identifier
spl id: a61342ff-6a0f-4604-8e4c-143a8d574313
spl set id: 85759f43-2903-48ff-939e-46f9661a1613

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.