FDA.reportPublic FDA data

Sun-Kissed Suncream

Manufacturer
LEE & GEN GLOBAL CORPORATION | Swiss-American CDMO, LLC
Effective date
2022-05-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:49:29

Label at a glance#

ProductSun-Kissed Suncream
Active ingredientZINC OXIDE, OCTINOXATE, OCTISALATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OCTINOXATE 7.5%
OCTISALATE 3.0%
ZINC OXIDE 8.0%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

Helps prevent sunburn

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:
■ apply liberally 15 minutes before sun exposure
■ reapply: after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 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 value of 15 or higher and other sun protection measures including:
– limit time in the sun, especially from 10 a.m. – 2 p.m.
– wear long-sleeved shirts, pants, hats and sunglasses
■ children under 6 months of age: ask a doctor

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, Cyclopentasiloxane, Ethylhexyl Isononanoate, Butylene Glycol, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Dimethicone, Phenoxyethanol, Sodium Chloride, Triethoxycaprylylsilane, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Iodopropynyl Butylcarbamate, Ascorbyl Palmitate, BHT, Retinyl Palmitate, Dipropylene Glycol, Zea Mays (Corn) Oil, Tocopherol

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sunlight

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
78493-001-022024-01-30C16284748780-11030e365-057c-111a-e063-dadaa90a10e278493-001 Sun-Kissed Suncream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78493-001-01Sun-Kissed Suncream88.7 mL in 1 TUBECREAM88.71
78493-001-02Sun-Kissed Suncream1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78493-001SUN-KISSED SUNCREAM (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [LEE & GEN GLOBAL CORPORATION]1Legacy NDC, 2 package rows20220506_6b76c675-4b0e-4b41-b7d8-916ffef0e05c.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78493-00178493-001-01, 78493-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
ETHYLHEXYL ISONONANOATEI6KB4GE3K4IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
DIMETHICONE92RU3N3Y1OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM CHLORIDE451W47IQ8XIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
DIMETHICONE/PEG-10/15 CROSSPOLYMER21AS8B1BSSIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)H895X08VNQIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
ASCORBYL PALMITATEQN83US2B0NIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
DIPROPYLENE GLYCOLE107L85C40IACT
CORN OIL8470G57WFMIACT
TOCOPHEROLR0ZB2556P8IACT
ZINC OXIDESOI2LOH54ZACTIM
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB

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
de4ca8b8-1fd1-2635-e053-2995a90a0c3d6b76c675-4b0e-4b41-b7d8-916ffef0e05c2022-05-05WarningsExact identifier
spl id: de4ca8b8-1fd1-2635-e053-2995a90a0c3d
spl set id: 6b76c675-4b0e-4b41-b7d8-916ffef0e05c

Reported adverse events (FAERS/openFDA)#

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