FDA.reportPublic FDA data

Le Lou Collagen Day Cream SPF 30

Manufacturer
Dougoud Cosmetics, LLC
Effective date
2017-02-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:19:54

Label at a glance#

ProductLe Lou Collagen Day SPF 30
Active ingredientOCTINOXATE, OCTISALATE, ZINC OXIDE
Label structure8 sections

Indications and uses

Helps prevent sunburn. If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15-minutes before sun exposure.  Reapply:  * At least every two-hours.  * Immediately after swimming, sweating or towel drying. ​SUN PROTECTION MEASURES: ​Spending time in the sun increases your risk of skin cancer and early sun again.  To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Octinoxate  7.50%

Octisalate  3.00%

Zinc Oxide  3.00%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

USES:

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS:

WARNINGS SECTION

  • For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or borken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes.  Rinse with water to remove.

Stop use and consult physician

OTC - STOP USE SECTION

if irritation or rash develops.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swalloed, get medical help or contact poison control center immediately.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15-minutes before sun exposure.  Reapply:  * At least every two-hours.  * Immediately after swimming, sweating or towel drying.

​SUN PROTECTION MEASURES: ​Spending time in the sun increases your risk of skin cancer and early sun again.  To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:

  • Limit time in the sun, especially between 10 am and 2 pm.
  • Wear long sleeve shirts, pants, hats and sunglasses.
  • For children under 6-months, consult a physician.

​OTHER INGREDIENTS:

INACTIVE INGREDIENT SECTION

Aloe barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbic Acid (Vitamin C), Butyropermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Cetearyl Alcohol, Cetearyl Olivate, Cocamidopropyl Betaine, Cucumis Sativus (Cucumber) extract, Cyclopentasiloxane, Cyclotetrasiloxane, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Oil, Glyceryl Sterate, PEG-100 Stearate, C13-14 Isoparaffin, Hydrolyzed Collagen, Isopropyl Myristate, Laureth-7, Magnifera Indica (Mango) Butter, Parfum (Fragrance), Phenoxyethanol, Polyacrylamide, Punica Granatum (Pomegranate) Extract, Sorbitan Olivate, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol.

OTHER INFORMATION:

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sunlight.

Questions or Comments?

OTC - QUESTIONS SECTION

Distributed by Dougoud Cosmetics, LLC, sales@dougoud.com, Miami, FL USA

PACKAGE LABELING:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70833-75870833-758-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
SHEA BUTTERK49155WL9YIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL OLIVATE58B69Q84JOIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
CUCUMBERYY7C30VXJTIACT
CYCLOMETHICONE 50THT5PCI0RIACT
CYCLOMETHICONE 4CZ227117JEIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
SUNFLOWER OIL3W1JG795YIIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LAURETH-7Z95S6G8201IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POMEGRANATE56687D1Z4DIACT
SORBITAN OLIVATEMDL271E3GRIACT
EDETATE SODIUMMP1J8420LUIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIM

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
0724f11f-3f27-78c4-e063-6394a90a077da800a169-48ec-4d82-825d-633bc2bfbed82023-10-07WarningsExact identifier
spl set id: a800a169-48ec-4d82-825d-633bc2bfbed8

Reported adverse events (FAERS/openFDA)#

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