anna lotan Premium BB Cream SPF46 Natural Beige — v3

anna lotan Premium BB Cream SPF46 Natural Beige

7 Views

Version

v3

Effective date

September 24, 2025

Original packager

Yes

Sections captured

11

Identifiers

Document ID
b223f402-9d5f-429c-b9af-2fd2a7e13827
Set ID
5a7765e5-933a-4665-8fb0-50b10c1dd41b
Application numbers
M020
Product NDCs
76446-042
Package NDCs
76446-042-30
Original packager NDCs

Names & Manufacturers

Brand names
anna lotan Premium BB Cream SPF46 Natural Beige
Generic names
TITANIUM DIOXIDE, OCTINOXATE
Manufacturer names
Anna Lotan Ltd
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
OCTINOXATE, TITANIUM DIOXIDE
Routes
TOPICAL
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
UNII
15FIX9V2JP, 4Y5P7MUD51
UPC
0850034338033

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active Ingredients Titanium Dioxide 16% Octinoxate 6.99%
Dosage And Administration (1)

Sequence 1

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 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 Ingredient (1)

Sequence 1

Inactive Ingredients Water, Caprylic/Capric Triglyceride, Dicaprylyl Ether, Cyclopentasiloxane, Talc, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Cyclohexasiloxane, Cetearyl Ethylhexanoate, Methyl Methacrylate Crosspolymer, Dipalmitoyl Hydroxyproline, Myristyl Myristate, Phenoxyethanol, Stearalkonium Hectorite, Microcrystalline Wax, Sodium Chloride, Paraffin, Polysilicone-11, Propylene Carbonate, Ethylhexylglycerin, Tocopherol, Helianthus Annuus (Sunflower) Seed Oil, BHT, Iron Oxides (CI 77491, CI 77492, CI 77499).
Indications And Usage (1)

Sequence 1

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.
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (1)

Sequence 1

Packaging Natural Beige-042
Purpose (1)

Sequence 1

Purpose: Sunscreen
Questions (1)

Sequence 1

Questions or comments info@annalotanusa.com Tel: (781) 281 0954
Spl Product Data Elements (1)

Sequence 1

anna lotan Premium BB Cream SPF46 Natural Beige Titanium Dioxide, Octinoxate TITANIUM DIOXIDE TITANIUM DIOXIDE OCTINOXATE OCTINOXATE WATER MEDIUM-CHAIN TRIGLYCERIDES DICAPRYLYL ETHER CYCLOMETHICONE 5 TALC CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) DIMETHICONE, UNSPECIFIED CYCLOMETHICONE 6 CETEARYL ETHYLHEXANOATE METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER DIPALMITOYL HYDROXYPROLINE MYRISTYL MYRISTATE PHENOXYETHANOL STEARALKONIUM HECTORITE MICROCRYSTALLINE WAX SODIUM CHLORIDE PARAFFIN DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) PROPYLENE CARBONATE ETHYLHEXYLGLYCERIN TOCOPHEROL SUNFLOWER OIL BUTYLATED HYDROXYTOLUENE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE
Spl Unclassified Section (2)

Sequence 1

Drug Facts

Sequence 2

PRO SUN Select Natural Beige 2 for normal/dry skin A multi-functional formula that serves as an optimal day care for normal to dry skin types, giving long lasting coverage, moisturisation and a wrinkle-relaxing effect. • A concentrated formula. A little will go a long way. • Applied in the morning, still looks great at the end of a busy day. • Formulated as a W/O emulsion that naturally repels water. However, care should be taken when regularly used on skin with enlarged pores! • Excellent spreading and adherence on the skin, offering optimal coverage for discolorations, including under eye dark circles! • A targeted combination of the amino acid proline and palm oil enhances skin penetration and provides a “plumping” anti-wrinkle effect, making it ideal for dry, mature skin. • Enriched with emollient oils that smooth the skin and prevent the typical accentuation of fine lines common with many concealing makeup products. • Vitamin E acts as antioxidant minimizing free radical damage. • Premium BB Cream combines concealing opacity with a light translucent veil which becomes apparent once the cream is fully absorbed. This veil allows your natural skin tone to shine through. Directions: Using sparingly, carefully spread the cream with fingertip massage to form an even layer on face, under eye area or wherever required until a smooth, even coverage is obtained. US Distribution: Anna Lotan USA Inc. 16 Wheeling Ave, Woburn, MA 01801 www.annalotanusa.com
Warnings (1)

Sequence 1

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.

OpenFDA raw payload

{'application_number': ['M020'],
 'brand_name': ['anna lotan Premium BB Cream SPF46 Natural Beige'],
 'generic_name': ['TITANIUM DIOXIDE, OCTINOXATE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Anna Lotan Ltd'],
 'package_ndc': ['76446-042-30'],
 'product_ndc': ['76446-042'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'spl_id': ['b223f402-9d5f-429c-b9af-2fd2a7e13827'],
 'spl_set_id': ['5a7765e5-933a-4665-8fb0-50b10c1dd41b'],
 'substance_name': ['OCTINOXATE', 'TITANIUM DIOXIDE'],
 'unii': ['4Y5P7MUD51', '15FIX9V2JP'],
 'upc': ['0850034338033']}