LOCCITANE EN PROVENCE LIGHT COMFORTING SPF 15- avobenzone, homosalate, octinoxate, octisalate, octocrylene cream

LOCCITANE EN PROVENCE LIGHT COMFORTING SPF 15 by

Drug Labeling and Warnings

LOCCITANE EN PROVENCE LIGHT COMFORTING SPF 15 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 9%

OCTINOXATE 7.5%

OCTISALATE 5%

OCTOCRYLENE 9%

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 15 minutes before sun exposure

Reapply at least every 2 hours

Use 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

Protection the product in this container from excessive heat and direct sun.

Inactive Ingredients:

AQUA/WATER - GLYCERIN - BUTYROSPERMUM PARKII (SHEA) BUTTER - CORN STARCH MODIFIED - DIMETHICONE - CETEARYL ALCOHOL - POTASSIUM CETYL PHOSPHATE - GLYCERYL STEARATE - PEG-100 STEARATE - COCOS NUCIFERA (COCONUT) OIL - LINUM USITATISSIMUM (LINSEED) SEED EXTRACT - MEL EXTRACT/HONEY EXTRACT - ALTHAEA OFFICINALIS ROOT EXTRACT - PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) FRUIT EXTRAT - CETEARETH-33 - BUTYLENE GLYCOL - XANTHAN GUM - TOCOPHERYL ACETATE - ETHYLHEXYLGLYCERIN - ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER - DISODIUM EDTA - ALCOHOL - SODIUM HYDROXIDE - UREA - TOCOPHEROL - PHENOXYETHANOL - CHLORPHENESIN - PARFUM/FRAGRANCE - BENZYL ALCOHOL - LINALOOL - COUMARIN - CITRONELLOL - ALPHA-ISOMETHYL IONONE - GERANIOL - BENZYL SALICYLATE - HYDROXYCITRONELLAL.

Questions or comments ?

Call toll free 1 888 623 2880

Package Labeling:

INGREDIENTS AND APPEARANCE

LOCCITANE EN PROVENCE LIGHT COMFORTING SPF 15 
avobenzone, homosalate, octinoxate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10345-102
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	90 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	90 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SHEA BUTTER (UNII: K49155WL9Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
COCONUT OIL (UNII: Q9L0O73W7L)
FLAX SEED (UNII: 4110YT348C)
HONEY (UNII: Y9H1V576FH)
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
ALMOND (UNII: 3Z252A2K9G)
CETEARETH-33 (UNII: R42C2O714B)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
XANTHAN GUM (UNII: TTV12P4NEE)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALCOHOL (UNII: 3K9958V90M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
UREA (UNII: 8W8T17847W)
TOCOPHEROL (UNII: R0ZB2556P8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
GERANIOL (UNII: L837108USY)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10345-102-01	1 in 1 BOX	12/01/2019
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 final	part352	12/01/2019

Labeler - LABORATOIRES M&L (262533623)