Premium BB Cream UVA/UVB SPF36 1 Natural

Premium BB Cream UVA/UVB SPF36 1 Natural by

Drug Labeling and Warnings

Premium BB Cream UVA/UVB SPF36 1 Natural by is a Otc medication manufactured, distributed, or labeled by Anna Lotan Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PREMIUM BB CREAM UVA/UVB SPF36 1 NATURAL- titanium dioxide, octinoxate cream 
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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Premium BB Cream UVA/UVB SPF36 1 Natural

Active Ingredients

Titanium Dioxide 15%
Octinoxate 7%

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 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 your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF or 15 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(Aqua), Caprylic/Capric Triglyceride, Cyclopentasiloxane, Dicaprylyl Ether, Talc,  Cetyl Peg/PPG-10/1 Dimethicone, Iron Oxide Dimethicone, Methyl Methacrylate Crosspolymer, Cetearyl Ethylhexanoate, Dipalmitoyl Hydroxyproline, Myristyl Myristate, Ozokerite, Stearic Acid, Sodium Chloride, Stearalkonium Hectorite, Propylene Carbonate, Squalane, Polysilicone-11, Tocopherol, Phenoxyethanol, Beta-Sitosterol, Fragrance (Parfum), Ethylhexylglycerin, Aluminum Hydroxide.

Questions or Commerce

info@annalotan-usa.com Tel:+972 4 6295000

Description

Premium B.B Cream

A "3 in one" formula that provides long lasting moisturization and UV protection while perfectly concealing uneven skin tone. Serves as an optimal day care for normal to dry skin types.

• Formulated as a Water in Oil emulsion that adheres to the skin providing long lasting benefit.
• Leaves a pleasant glow on the skin without the typical shine of a W/O emulsion.
• Excellent adherence to the skin with optimal coverage of discolorations.
  
• A Targeted combination of the amino-acid Proline and Palm Oil enhance skin penetration and provide a "plumping" anti-wrinkle effect, making it ideal for dry, mature skin.
• The emollient oils smooth the skin and prevent the typical accentuation of fine lines common with many concealing makeup products.
• Vitamin E acts as a free radical scavenger and maintains the quality of the natural oils in the cream.

Directions: Use sparingly, and spread with several massage motions until a smooth even coverage is obtained.

Note:Since this is an occlusive [W/O] formula it may not be compatible with oily, large pored skin. Testing before continuous use is recommended!

Premium BB Cream UVA/UVB SPF36 1 Natural

PREMIUM BB CREAM UVA/UVB SPF36 1 NATURAL 
titanium dioxide, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76446-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.5 g  in 30 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.1 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
TALC (UNII: 7SEV7J4R1U)
METHYL METHACRYLATE (UNII: 196OC77688)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SQUALANE (UNII: GW89575KF9)
TOCOPHEROL (UNII: R0ZB2556P8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76446-012-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/02/2016	08/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/02/2016	08/31/2019

Labeler - Anna Lotan Ltd (600458368)

Establishment
Name	Address	ID/FEI	Business Operations
Anna Lotan Ltd		600458368	manufacture(76446-012)

Revised: 8/2019

Document Id: 9141a61f-4ddd-0192-e053-2995a90a9a3d

34390-5

Set id: 7b4385db-4c8b-480a-92ef-8e290a416cbe

Version: 3

Effective Time: 20190829