ANNA LOTAN PRO PORCELAIN COVER SPF32 TINTED WITH BROAD SPECTRUM PROTECTION FOR ALL SKIN TYPES- titanium dioxide, octinoxate lotion 
Anna Lotan Ltd

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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anna lotan PRO PORCELAIN COVER SPF32 Tinted Lotion with Broad Spectrum Protection for All Skin Types

anna lotan PRO PORCELAIN COVER SPF32 Tinted Lotion with Broad Spectrum Protection for All Skin Types


Active Ingredients

Titanium Dioxide  13.40%
Ethylhexyl Methoxycinnamate  7.50%

Purpose:

Sunscreen

Uses

  • Helps to prevent sunburn
  • If used as directed with other sun protective 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.  If contact occurs rinse thoroughly with water to remove.

Stop use and ask a doctor

if rash occurs.

Keep out of reach of children.

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

Directions

  • Apply liberally 15 minutes before sun exposure.
  • Reapply:  - after 40 minutes of swimming or sweating. - immediately after towel drying. - at least every 2 hours.
  • Sun Protection Measures.  Spending time in the sun increases the risk of skin cancer and early skin aging.  To decrease this risk, regularly use a sunscreen with a broad spectrum  SPF of 15 or higher and other protection measures including:
    • Limit time in sun from 10 a.m. - 2 p.m.
    • Wear long-sleeve shirts, pants, hats and sunglasses.
  • Children under 6 months:  Ask a doctor.

Inactive Ingredients

Water, Cyclopentasiloxane, Dicaprylyl Ether, Trimethylsiloxysilicate, Propylene Glycol, Sea Water, Dimethiconol, PEG/PPG-18/18 Dimethicone, Glycerin, Palmitoyl Hydrolyzed Wheat Protein, Hydrolyzed Pearl, Sea Salt, Linoleic Acid, Carthamus Tinctorius Oil, Tocopheryl Acetate, Nelumbo Nucifera Flower Extract, Retinyl Palmitate, Iron Oxide (C.I. 77492), Alumina, Dimethicone Crosspolymer, Polysorbate 20, Iron Oxide (C.I. 77491), Phenoxyethanol, Isopropyl Titanium Triisostearate, Simethicone, Silica, Lonicera Caprifolium (Honeysuckle) Extract, Triethoxycaprylylsilane, Iron Oxide (C.I. 77499), Butylene Glycol, Isopropyl Myristate, Fragrance, Lonicera Japonica (Honeysuckle) Flower Extract, Glycine Soja Oil.

Questions or Comments?

info@annalotan.com  Tel. +972 4 6295000

anna lotan PRO PORCELAIN COVER SPF32 Tinted Lotion with Broad Spectrum Protection for All Skin Types 30ml (76446-006-30)

Porcelain Cover Label

ANNA LOTAN PRO PORCELAIN COVER SPF32 TINTED WITH BROAD SPECTRUM PROTECTION FOR ALL SKIN TYPES 
titanium dioxide, octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76446-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE134 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
GLYCERIN (UNII: PDC6A3C0OX)  
SEA SALT (UNII: 87GE52P74G)  
LINOLEIC ACID (UNII: 9KJL21T0QJ)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76446-006-301 in 1 CARTON11/11/201308/31/2019
130 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/11/201308/31/2019
Labeler - Anna Lotan Ltd (600458368)
Establishment
NameAddressID/FEIBusiness Operations
Anna Lotan Ltd600458368manufacture(76446-006)

Revised: 8/2019
 
Anna Lotan Ltd