Label: ANNA LOTAN PREMIUM BB CREAM SPF46 PALE BEIGE- titanium dioxide, octinoxate cream
- NDC Code(s): 76446-041-30
- Packager: Anna Lotan Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated September 14, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose:
- Uses
- Warnings
-
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 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).
- Questions or comments
-
SPL UNCLASSIFIED SECTION
PRO
SUN Select
Pale Beige 1
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 - Packaging
-
INGREDIENTS AND APPEARANCE
ANNA LOTAN PREMIUM BB CREAM SPF46 PALE BEIGE
titanium dioxide, octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76446-041 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 16 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6.99 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DICAPRYLYL ETHER (UNII: 77JZM5516Z) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) TALC (UNII: 7SEV7J4R1U) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE 6 (UNII: XHK3U310BA) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) PHENOXYETHANOL (UNII: HIE492ZZ3T) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) SODIUM CHLORIDE (UNII: 451W47IQ8X) PARAFFIN (UNII: I9O0E3H2ZE) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TOCOPHEROL (UNII: R0ZB2556P8) SUNFLOWER OIL (UNII: 3W1JG795YI) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76446-041-30 1 in 1 CARTON 09/15/2023 1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 09/15/2023 Labeler - Anna Lotan Ltd (600458368)