IMMORTELLE BRIGHTENING SHIELD AND SUNSCREEN SPF 40  - titanium dioxide cream 
LABORATOIRES M&L

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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ACTIVE INGREDIENT

CI 77891/TITANIUM DIOXIDE  11.52% 

Uses:

- Helps prevent sunburn. 

- Higher SPF gives more sunburn protection. 

- Provides moderate protection against sunburn.

Warnings:

- For external use only.

When using this product:

- Keep out of eyes. Rinse with water to remove.

Stop use and ask doctor if:

- Rash or irritation develops and lasts.

Keep Out Of Reach Of Children

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

Direction:

- Apply evenly each morning before sun exposure. Reapply as needed.  - Do not use on infants under 6 months.

Other information:

high sun protection product  Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

INACTIVE INGREDIENTS:

CYCLOMETHICONE - AQUA/WATER - POLYGLYCERYL-3 POLYDIMETHYL - SILOXYETHYL DIMETHICONE - CORN STARCH MODIFIED - BELLIS PERENNIS (DAISY) FLOWER EXTRACT - ALUMINUM HYDROXIDE - STEARIC ACID - PEG-12 DIMETHICONE - SODIUM CHLORIDE - HELICHRYSUM ITALICUM (FLOWER) OIL - OENOTHERA BIENNIS (EVENING PRIMROSE) OIL - HELIANTHUS ANNUUS (SUNFLOWER) SEED EXTRACT - TROPAEOLUM MAJUS EXTRACT - HEDERA HELIX (IVY) EXTRACT - BORAGO OFFICINALIS SEED OIL - BIOTIN - PEG/PPG-18/18 DIMETHICONE - GLYCERIN - PARFUM/FRAGRANCE - TOCOPHERYL ACETATE - PEG-8 - SUCROSE PALMITATE - CAPRYLYL GLYCOL - BUTYLENE GLYCOL - PPG-1-PEG-9 LAURYL GLYCOL ETHER - ETHYLHEXYLGLYCERIN - GLYCERYL LINOLEATE - PHYTIC ACID - SODIUM POLYACRYLATE - PHENOXYETHANOL - BENZOIC ACID - DEHYDROACETIC ACID - POLYAMINOPROPYL BIGUANIDE - POTASSIUM SORBATE - BENZYL SALICYLATE - LINALOOL - ALPHA-ISOMETHYL IONONE - HEXYL CINNAMAL.

Purpose

Sunscreen

Immortelle Brightening Shield And Sunscreen Label 1

Immortelle Brightening Shield And Sunscreen Label 2

Immortelle Brightening Shield And Sunscreen Outer Package 1

Immortelle Brightening Shield And Sunscreen Outer Package 2

IMMORTELLE BRIGHTENING SHIELD AND SUNSCREEN SPF 40  
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10345-024
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE115.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 
WATER 
STARCH, CORN 
BELLIS PERENNIS FLOWER 
ALUMINUM HYDROXIDE 
STEARIC ACID 
DIMETHICONE 
SODIUM CHLORIDE 
HELICHRYSUM ITALICUM FLOWER OIL 
EVENING PRIMROSE OIL 
SUNFLOWER SEED 
TROPAEOLUM MAJUS 
HEDERA HELIX LEAF 
BORAGE OIL 
BIOTIN 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
SUCROSE PALMITATE 
CAPRYLYL GLYCOL 
BUTYLENE GLYCOL 
ETHYLHEXYLGLYCERIN 
GLYCERYL LINOLEATE 
SODIUM POLYACRYLATE (2500000 MW) 
PHENOXYETHANOL 
BENZOIC ACID 
DEHYDROACETIC ACID 
POLYAMINOPROPYL BIGUANIDE 
POTASSIUM SORBATE 
BENZYL SALICYLATE 
LINALOOL, (+/-)- 
ISOMETHYL-.ALPHA.-IONONE 
.ALPHA.-HEXYLCINNAMALDEHYDE 
Packaging
#Item CodePackage Description
1NDC:10345-024-011 in 1 PACKAGE
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/13/2011
Labeler - LABORATOIRES M&L (262533623)

Revised: 04/2013
Document Id: 311d6252-ce57-418b-adfe-ee2a71b519e2
Set id: dd67bc6f-56dd-4062-8a08-51e0b5dcd530
Version: 2
Effective Time: 20130425
 
LABORATOIRES M&L