LOCCITANE EN PROVENCE IMMORTELLE PRECIEUSE LIGHT SPF20- avobenzone, homosalate, octinoxate, octisalate, octocrylene cream

LOCCITANE EN PROVENCE IMMORTELLE PRECIEUSE LIGHT SPF20 by

Drug Labeling and Warnings

LOCCITANE EN PROVENCE IMMORTELLE PRECIEUSE LIGHT SPF20 by is a Otc medication manufactured, distributed, or labeled by LABORATOIRES M&L. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Avobenzone 3%
Homosalate 5%
Octinoxate 7.5%
Octisalate 5%
Octocrylene 5%

Purpose

Sunscreen

Uses

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

Warnings

For external use only.

Do not use

on damaged or broken skin.

When usning 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 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water-resistant sunscreen if swimming or sweating
• Sun Protection Measures. Spening time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a suncreen 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:

AQUA/WATER - GLYCERIN - COCO-CAPRYLATE/CAPRATE -CORN STARCH MODIFIED - CETEARYL ALCOHOL - DIMETHICONE - POTASSIUM CETYL PHOSPHATE - HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER - HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL - HELICHRYSUM ITALICUM FLOWER OIL - HELICHRYSUM ITALICUM EXTRACT - OENOTHERA BIENNIS (EVENING PRIMROSE) OIL - BORAGO OFFICINALIS SEED OIL - CETEARYL GLUCOSIDE - CHLORPHENESIN - TOCOPHEROL - SUCROSE PALMITTE - DISODIUM EDTA - POLYSORBATE 60 - SORBITAN ISOSTEARATE - ADENOSINE - GLYCERYL LINOLEATE - CITRIC ACID - PHENOXYETHANOL - SODIUM BENZOATE - POTASSIUM SORBATE - PARFUM/FRAGRANCE - HYXYL CINNAMAL - BENZYL SALICYLATE - ALPHA-ISOMETHYL IONONE - LINALOOL - CITRAL - LIMONENE

Questions or comments ?

Call toll free 1 888 623 2880

Package Labeling:

INGREDIENTS AND APPEARANCE

LOCCITANE EN PROVENCE IMMORTELLE PRECIEUSE LIGHT SPF20 
avobenzone, homosalate, octinoxate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10345-101
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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HELICHRYSUM ITALICUM FLOWER OIL (UNII: O97ZV7726K)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
BORAGE SEED OIL (UNII: F8XAG1755S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CHLORPHENESIN (UNII: I670DAL4SZ)
TOCOPHEROL (UNII: R0ZB2556P8)
SUCROSE PALMITATE (UNII: 3OSQ643ZK5)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
ADENOSINE (UNII: K72T3FS567)
GLYCERYL MONOLINOLEATE (UNII: 4763AXI84L)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CITRAL (UNII: T7EU0O9VPP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10345-101-01	1 in 1 BOX	01/15/2019
1		50 mL in 1 JAR; 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	01/15/2019

Labeler - LABORATOIRES M&L (262533623)