FDA.reportPublic FDA data

Ultra Replenishing Sunscreen SPF 40

Manufacturer
CosMedical Technologies, LLC
Effective date
2023-11-10
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:02:14

Label at a glance#

ProductUltra Replenishing Sunscreen SPF 40
Active ingredientHOMOSALATE, OCTOCRYLENE, ZINC OXIDE, OCTISALATE
Label structure7 sections

Indications and uses

Helps prevent sunburn

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Homosalate 8% Octisalate 5% Octocrylene 5% Zinc Oxide 8%


OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

INACTIVE INGREDIENT SECTION

Water C12-15 Alkyl Benzoate Glycerin Mica Polyglyceryl-2 Stearate Glyceryl Stearate Steareth-21 Stearyl Alcohol Dimethicone Phenoxyethanol Simmondsia Chinensis (Jojoba) Seed Oil Steareth-2 Fructose Cocos Nucifera (Coconut) Oil Citric Acid Ethylhexylglycerin Hydroxyethylcellulose Chlorphenesin Hydrolyzed Rice Protein Titanium Dioxide (CI 77891) Tocopheryl Acetate Kaempferia Galanga Root Extract Aloe Barbadensis Leaf Juice Sodium Phytate Lavandula Angustifolia (Lavender) Oil Withania Somnifera Flower Extract Iron Oxide (CI 77492) Iron Oxide (CI 77491) Citrus Aurantium Dulcis (Orange) Peel Oil Silica Dimethylmethoxy Chromanol Vanilla Planifolia Fruit Extract Iron Oxide (CI 77499)































Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions • Apply liberally and evenly 15 minutes before sun exposure. • Reapply: at least every 2 hours • Use a water-resistant sunscreen if swimming or sweating. • 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 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.






PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ULTRAREP50ULTRAREP50Sample PackettesSample Packettes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70060-1901-1Ultra Replenishing Sunscreen SPF 4050 mL in 1 BOTTLE, PLASTICCREAM505
70060-1901-2Ultra Replenishing Sunscreen SPF 401.5 mL in 1 PACKETCREAM1.55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70060-1901ULTRA REPLENISHING SUNSCREEN SPF 40 (HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXYIDE CREAM) CREAM [COSMEDICAL TECHNOLOGIES, LLC]5Current NDC, Legacy NDC, 2 package rows20231116_92ad5d7a-9adb-7d55-e053-2995a90a80e7.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70060-190170060-1901-1, 70060-1901-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEARETH-2V56DFE46J5IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CHLORPHENESINI670DAL4SZIACT
FERRIC OXIDE RED1K09F3G675IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
KAEMPFERIA GALANGA ROOT7B7U9D12AIIACT
ALOE VERA LEAFZY81Z83H0XIACT
PHYTATE SODIUM88496G1ERLIACT
WATER059QF0KO0RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
STEARETH-2153J3F32P58IACT
MICAV8A1AW0880IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GLYCERINPDC6A3C0OXIACT
POLYGLYCERYL-2 STEARATE253MC0P0YVIACT
VANILLAQ74T35078HIACT
DIMETHYLMETHOXY CHROMANOLXBH432G01FIACT
DIMETHICONE92RU3N3Y1OIACT
COCONUT OILQ9L0O73W7LIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
STEARYL ALCOHOL2KR89I4H1YIACT
PHENOXYETHANOLHIE492ZZ3TIACT
JOJOBA OIL724GKU717MIACT
FRUCTOSE6YSS42VSEVIACT
ENGLISH LAVENDER OILZBP1YXW0H8IACT
WITHANIA SOMNIFERA FLOWER2HZ95R7082IACT
ORANGE OILAKN3KSD11BIACT
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ZINC OXIDESOI2LOH54ZACTIB
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
Ultra Replenishing Sunscreen SPF 40HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXYIDE CREAMCosMedical Technologies, LLC92ad5d7a-9adb-7d55-e053-2995a90a80e72023-11-10WarningsExact identifier
ndc (package): 70060-1901-1
ndc (package): 70060-1901-2
ndc (product): 70060-1901
ndc11 (package): 70060190101
ndc11 (package): 70060190102
spl id: 09cca94c-caf2-1c88-e063-6294a90a90e5
spl set id: 92ad5d7a-9adb-7d55-e053-2995a90a80e7

Reported adverse events (FAERS/openFDA)#

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