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

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

Drug Labeling and Warnings

anna lotan PRO PORCELAIN COVER SPF32 Tinted with Broad Spectrum Protection for All Skin Types by is a Otc medication manufactured, distributed, or labeled by Anna Lotan Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76446-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	134 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76446-006-30	1 in 1 CARTON	11/11/2013	08/31/2019
1		30 mL in 1 BOTTLE, DISPENSING; 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	11/11/2013	08/31/2019

Labeler - Anna Lotan Ltd (600458368)

Establishment
Name	Address	ID/FEI	Business Operations
Anna Lotan Ltd		600458368	manufacture(76446-006)

Revised: 8/2019

Document Id: 9141d594-45ce-46bc-e053-2a95a90a2bb4

34390-5

Set id: 28ea8c70-fe10-4d0d-93b9-a0f63d7f804b

Version: 3

Effective Time: 20190829