FDA.reportPublic FDA data

UNIWELL AQUA SUNCREAM

Manufacturer
uniwell LTD | Cosmecca Korea Co., Ltd.
Effective date
2017-06-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:50:06

Label at a glance#

ProductUNIWELL AQUA SUNCREAM
Active ingredientOctinoxate, OCTISALATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OCTINOXATE 7.00%

OCTISALATE 4.50%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

Helps prevent sunburn

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INACTIVE INGREDIENT SECTION

Water, Butylene Glycol, Diethylamino Hydroxybenzoyl Hexyl Benzoate, C12-15 Alkyl Benzoate, Niacinamide, Methyl Methacrylate Crosspolymer, Phenylbenzimidazole Sulfonic Acid, Cetearyl Alcohol, Glyceryl Stearate, Cetearyl Olivate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Sorbitan Olivate, Polysorbate 60, PEG-100 Stearate, Sorbitan Stearate, Dimethicone, Polyacrylate-13, Panthenol, Caprylyl Glycol, Sodium Hydroxide, Polyisobutene, Ethylhexylglycerin, Citrus Aurantium Dulcis (Orange) Oil, 1,2-Hexanediol, Disodium EDTA, Propolis Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Camellia Sinensis Leaf Extract, Lavandula Angustifolia (Lavender) Oil, Adenosine, Polysorbate 20, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Sorbitan Isostearate, Panax Ginseng Root Extract, Portulaca Oleracea Extract, Ecklonia cava Extract, Codium Tomentosum Extract, Gelidium Cartilagineum Extract, Hizikia Fusiforme Extract, Glycerin, Geranium Maculatum Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Santalum Album (Sandalwood) Oil, Rose Flower Oil, Chamomilla Recutita (Matricaria) Flower Oil, Olea Europaea (Olive) Leaf Extract, Alcohol, Anthemis Nobilis Flower Extract, Brassica Oleracea Italica (Broccoli) Extract, Phenoxyethanol, Styrax Benzoin Gum, Commiphora Myrrha Oil, Aloe Barbadensis Leaf Juice, Gossypium Herbaceum (Cotton) Extract, Potassium sorbate, Sodium Benzoate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71502-001-022020-01-31C16284748780-19d75b9d1-0fb4-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71502-001-01UNIWELL AQUA SUNCREAM50 mL in 1 CONTAINERCREAM501
71502-001-02UNIWELL AQUA SUNCREAM1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71502-001UNIWELL AQUA SUNCREAM (OCTINOXATE, OCTISALATE) CREAM [UNIWELL LTD]1Legacy NDC, 2 package rows20170613_dbee7ab2-3777-4ca5-9503-8e4866071c6e.zip

Products#

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

DailyMed product names page 1 of 2 · 58 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71502-00171502-001-01, 71502-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 56 matching rows.

Name, UNII, Kind table
NameUNIIKind
Octinoxate4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
WATER059QF0KO0RIACT
Butylene Glycol3XUS85K0RAIACT
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATEANQ870JD20IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
NIACINAMIDE25X51I8RD4IACT
ENSULIZOLE9YQ9DI1W42IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
Cetearyl Olivate58B69Q84JOIACT
BEMOTRIZINOLPWZ1720CBHIACT
Sorbitan OlivateMDL271E3GRIACT
Polysorbate 60CAL22UVI4MIACT
PEG-100 StearateYD01N1999RIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
DIMETHICONE92RU3N3Y1OIACT
POLYACRYLAMIDE (1500 MW)5D6TC4BRWVIACT
PanthenolWV9CM0O67ZIACT
Caprylyl Glycol00YIU5438UIACT
Sodium Hydroxide55X04QC32IIACT
POLYISOBUTYLENE (1000 MW)5XB3A63Y52IACT
Ethylhexylglycerin147D247K3PIACT
ORANGE OILAKN3KSD11BIACT
1,2-HexanediolTR046Y3K1GIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
PROPOLIS WAX6Y8XYV2NOFIACT
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP9YT4B71U8PIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
LAVENDER OILZBP1YXW0H8IACT
ADENOSINEK72T3FS567IACT
POLYSORBATE 207T1F30V5YHIACT
HAMAMELIS VIRGINIANA LEAFT07U1161SVIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
ASIAN GINSENGCUQ3A77YXIIACT
PURSLANEM6S840WXG5IACT
ECKLONIA CAVAUXX2N5V39PIACT
CODIUM TOMENTOSUMB8B45BRU87IACT
GELIDIUM CARTILAGINEUM37LBZ0E1UEIACT
SARGASSUM FUSIFORMEX436TJ4A11IACT

Source Document#

Source XML

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
7156cc2a-ca84-42d9-8e30-e6815403edbadbee7ab2-3777-4ca5-9503-8e4866071c6e2017-06-12WarningsExact identifier
spl id: 7156cc2a-ca84-42d9-8e30-e6815403edba
spl set id: dbee7ab2-3777-4ca5-9503-8e4866071c6e

Reported adverse events (FAERS/openFDA)#

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