GARNIER NUTRITIONISTE MOISTURE RESCUE LIGHTWEIGHT UV SPF 15- ensulizole and octinoxate lotion
L'Oreal USA Products Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients

Ensulizole 1.5%, Octinoxate 7.5%

Uses

Helps prevent sunburn. Higher SPF gives more sunburn protection.

Warnings

FOR EXTERNAL USE ONLY

When using this product

KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

Stop use and consult a doctor

IF RASH OR IRRITATION DEVELOPS AND LASTS.

Keep out of reach of children.

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISION CONTROL CENTER RIGHT AWAY.

Directions

Gently apply Moisture Rescue Lightweight UV-Lotion SPF 15 to face and neck daily prior to sun exposure.

Inactive ingredients

water, glycerin, allantoin, titanium dioxide, xanthan gum, palmitic acid, methylparaben, ethylparaben, isobutylparaben, butylparaben

image description

GARNIER NUTRITIONISTE MOISTURE RESCUE LIGHTWEIGHT UV SPF 15
ensulizole and octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49967-457
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42)	Ensulizole	15 mg in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALLANTOIN (UNII: 344S277G0Z)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STEARIC ACID (UNII: 4ELV7Z65AP)
XANTHAN GUM (UNII: TTV12P4NEE)
PALMITIC ACID (UNII: 2V16EO95H1)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49967-457-01	1 in 1 CARTON	06/01/2010	04/04/2014
1		133 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	06/01/2010	04/04/2014

Labeler - L'Oreal USA Products Inc (002136794)

Name	Address	ID/FEI	Business Operations
Establishment
L'Oreal USA Products Inc		624244349	manufacture(49967-457)

Revised: 1/2020

Document Id: 1f0d7fb4-b1d7-4cf1-beab-79d05689dbc4

Set id: 1e8a170b-4a99-4784-a6bb-9e231fc4aa61

Version: 8

Effective Time: 20200129

L'Oreal USA Products Inc