FDA.reportPublic FDA data

Aldana Skin Life - Sunscreen Broad Spectrum SPF 55 Water Resistant (80 Mins.)

Manufacturer
Cosmetic Solutions LLC
Effective date
2022-04-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:49:24

Label at a glance#

ProductAldana Skin Life - Sunscreen Broad Spectrum SPF 55 Water Resistant (80 Mins.)
Active ingredientOCTINOXATE, ZINC OXIDE
Label structure9 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply liberally and evenly 15 minutes before sun exposure. For children under 6 months of age: Ask a doctor. Reapply: At least 80 minutes after 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 of 15 or hig...

Storage and handling

Protect the product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS:

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%, Zinc Oxide 4.8%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

WARNINGS

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 use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Apply liberally and evenly 15 minutes before sun exposure. 1Reapply: At least 80 minutes after 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 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-sleeve shirts, pants, hats, and sunglasses.

1 For children under 6 months of age: Ask a doctor.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Hydrogenated Polybutene, Octyl Stearate, Polyglyceryl-4-Isostearate, Aloe Barbadensis Leaf Extract, Isopropyl Palmitate, Cyclomethicone, Sunflower Oil, Hydrogenated Microcrystalline Wax, Cetyl Dimethicone Copolyol, Cetyl Dimethicone, Hydrogenated Castor Oil, Sodium Chloride, Polyglyceryl-3-Oleate, Silica, Hexyl Laurate, Triethoxycaprylylsilane, Capryly Glycol, Methylisothiazolinone.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Protect the product in this container from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL - 60 G Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALDANA
SKIN LIFE

uv
PROTECTIVE

SUNSCREEN

BROAD SPECTRUM SPF 55

WATER RESISTANT (80 MINS.)

60 G (NET WT. 2 OZ)

PRINCIPAL DISPLAY PANEL - 60 G Bottle Label
PRINCIPAL DISPLAY PANEL - 60 G Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66163-5500-12024-01-30C16284748780-11030e365-04bd-111a-e063-dadaa90a10e2Aldana Skin Life - Sunscreen Broad Spectrum SPF 55 Water Resistant (80 Mins.)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66163-5500-1Aldana Skin Life - Sunscreen Broad Spectrum SPF 55 Water Resistant (80 Mins.)60 g in 1 BOTTLELOTION601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66163-5500ALDANA SKIN LIFE - SUNSCREEN BROAD SPECTRUM SPF 55 WATER RESISTANT (80 MINS.) (OCTINOXATE AND ZINC OXIDE) LOTION [COSMETIC SOLUTIONS LLC]1Legacy NDC, 1 package rows20220501_31f4a47e-4394-4e14-b727-a444b92d5fb1.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66163-550066163-5500-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
OCTYL STEARATE772Y4UFC8BIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
ALOE VERA LEAFZY81Z83H0XIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
CYCLOMETHICONENMQ347994ZIACT
SUNFLOWER OIL3W1JG795YIIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
SODIUM CHLORIDE451W47IQ8XIACT
POLYGLYCERYL-3 OLEATEXRQ165498BIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
HEXYL LAURATE4CG9F9W01QIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CAPRYLYL GLYCOL00YIU5438UIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT

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
0c5e1b63-460d-4346-bc50-0a04d716b38f31f4a47e-4394-4e14-b727-a444b92d5fb12022-04-12WarningsExact identifier
spl id: 0c5e1b63-460d-4346-bc50-0a04d716b38f
spl set id: 31f4a47e-4394-4e14-b727-a444b92d5fb1

Reported adverse events (FAERS/openFDA)#

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