LE LOU COLLAGEN DAY SPF 30- octinoxate, octisalate, zinc oxide cream
Dougoud Cosmetics, LLC

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Le Lou Collagen Day Cream SPF 30

Drug Facts

ACTIVE INGREDIENTS

Octinoxate 7.50%

Octisalate 3.00%

Zinc Oxide 3.00%

PURPOSE

Sunscreen

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.

WARNINGS:

For external use only.

Do not use

on damaged or borken skin.

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and consult physician

if irritation or rash develops.

Keep out of reach of children.

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

DIRECTIONS:

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:

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:

Protect this product from excessive heat and direct sunlight.

Questions or Comments?

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

PACKAGE LABELING:

Label

LE LOU COLLAGEN DAY SPF 30
octinoxate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70833-758
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 mg in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	30 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
SHEA BUTTER (UNII: K49155WL9Y)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CUCUMBER (UNII: YY7C30VXJT)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LAURETH-7 (UNII: Z95S6G8201)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POMEGRANATE (UNII: 56687D1Z4D)
SORBITAN OLIVATE (UNII: MDL271E3GR)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70833-758-01	113.4 g in 1 JAR; Type 0: Not a Combination Product	08/16/2016	07/25/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	08/16/2016	07/25/2019

Labeler - Dougoud Cosmetics, LLC (006843180)

Revised: 10/2023

Document Id: 0724f11f-3f27-78c4-e063-6394a90a077d

Set id: a800a169-48ec-4d82-825d-633bc2bfbed8

Version: 4

Effective Time: 20231007

Dougoud Cosmetics, LLC