UV BASE SPF 50- avobenzone, octinoxate, octisalate cream

UV Base SPF 50 by

Drug Labeling and Warnings

UV Base SPF 50 by is a Otc medication manufactured, distributed, or labeled by LUXE ART BEAUTE SAS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69879-120-30	1 in 1 CASE	03/26/2018
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/26/2018

Labeler - LUXE ART BEAUTE SAS (378611552)