UV BASE SPF 50- avobenzone, octinoxate, octisalate cream
LUXE ART BEAUTE SAS

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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UV Base SPF 50

Drug Facts

Active ingredients

Avobenzone 3%

Octinoxate 6.8%

Octisalate 4.5%

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 broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs

Keep out of reach of children.

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

Directions

Apply liberally and evenly 15 minutes before sun exposure
Reapply at least every 2 hours
Usa 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 a 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

Other information

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

Inactive ingredients

WATER, BUTYLENE GLYCOL, ISOTRIDECYL ISONONANOATE, DIMETHICONE, PENTYLENE GLYCOL, DEXTRIN PALMITATE, PHENOXYETHANOL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, PEG-60 GLYCERYL ISOSTEARATE, FRAGRANCE, CARBOMER, TOCOPHEROL, SODIUM HYDROXIDE, PALMITIC ACID, DISODIUM EDTA, BHT.

Package Labeling:

Label

UV BASE SPF 50
avobenzone, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69879-120
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	68 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT)
DIMETHICONE (UNII: 92RU3N3Y1O)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
PEG-60 GLYCERYL ISOSTEARATE (UNII: WQP0973914)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PALMITIC ACID (UNII: 2V16EO95H1)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69879-120-30	1 in 1 CASE	03/26/2018	08/21/2023
1		30 mL in 1 TUBE; 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	03/26/2018	08/21/2023

Labeler - LUXE ART BEAUTE SAS (378611552)

Revised: 9/2023

Document Id: 045f647f-5ae0-2c8c-e063-6394a90a2782

Set id: ab02adb4-3997-40cf-9c6d-ea5aa525cb6b

Version: 7

Effective Time: 20230902

LUXE ART BEAUTE SAS