Label: GR BB SPF 25- octinoxate, oxybenzone, titanium dioxide cream
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NDC Code(s):
82715-101-01,
82715-101-02,
82715-101-03,
82715-101-04, view more82715-101-05, 82715-101-06
- Packager: ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI
- 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 May 4, 2022
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
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Directions
• apply generously 15 minutes before the sun exposure • apply to cleansed skin • can be applied two coats to increase coverage • reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating
• 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 sun Broad Spectrum SPF value of 15 or higher and other protection measures including: • limit time in the sun, especially from 10 a.m. - 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses.
• children under 6 months of age: Ask a doctor - Other information
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Inactive ingredients
Water (Aqua), Cyclopentasiloxane, Isododecane, Glycerin, PEG-9 Polydimethylsiloxyethyl Dimethicone, Butylene Glycol, Phenyl Trimethicone, Talc, Acrylates/Dimethicone Copolymer, Silica Dimethyl Silylate, Sodium Chloride, Phenoxyethanol, Disteardimonium Hectorite, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethicone, Tocopheryl Acetate, PEG/PPG-18 /18 Dimethicone, White Bird of Paradise (Strelitzia nicolai) Seed Aril Extract, Propylene Carbonate, Pentylene Glycol, Potassium Sorbate, Disodium EDTA, Sorbic Acid, Triethoxycaprylylsilane, Lactic Acid, Serine, Sodium Lactate, Sorbitol, Urea, Magnesium Stearate, Fragrance, Silica, Isoceteth-10, Aluminum Hydroxide, Allantoin, Linalool, Mica*, Iron Oxides*, Bismuth Oxychloride*.
* contains one or more of these ingredients -
SPL UNCLASSIFIED SECTION
BB CREAM
BEAUTY BALM
Broad Spectrum SPF 25
All in One, Instantly Perfect Looking Skin!
• Gives a smooth finish look with its light and easy to apply texture.
• Provides hydration to the skin during the day.
• SPF 25 (UVA/UVB) protects your skin against the harmful sunrays.DERMATOLOGICALLY TESTED
Manufactured By:
ERKUL COSMETICS
San. Tic. A.Ş.
Petrol Ofisi Cad. No:1
Avcılar, Istanbul, Turkey,
34310Phone: +90 212 456 53 00
www.goldenrose.com.tr
info@goldenrose.com.trMADE IN TURKEY
Distributed By:
CELESTY LLC
3970 NW 167 TH ST.
MIAMI GARDENS,
FL 33054 – USAinfo@celesty.com
EU R.P. : Platin Beauty Consulting UG (haftungsbeschränkt)
Bardowicker Str. 6, 21335 Lüneburg/GERMANY - Packaging
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INGREDIENTS AND APPEARANCE
GR BB SPF 25
octinoxate, oxybenzone, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82715-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.5 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.25 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.95 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ISODODECANE (UNII: A8289P68Y2) GLYCERIN (UNII: PDC6A3C0OX) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) TALC (UNII: 7SEV7J4R1U) 2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOXYETHANOL (UNII: HIE492ZZ3T) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) DIMETHICONE (UNII: 92RU3N3Y1O) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) STRELITZIA NICOLAI WHOLE (UNII: YY9ZE10P9H) PROPYLENE CARBONATE (UNII: 8D08K3S51E) PENTYLENE GLYCOL (UNII: 50C1307PZG) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) SORBIC ACID (UNII: X045WJ989B) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) SERINE (UNII: 452VLY9402) SODIUM LACTATE (UNII: TU7HW0W0QT) SORBITOL (UNII: 506T60A25R) UREA (UNII: 8W8T17847W) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ISOCETETH-10 (UNII: 1K92T9919H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALLANTOIN (UNII: 344S277G0Z) LINALOOL, (+/-)- (UNII: D81QY6I88E) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82715-101-01 1 in 1 CARTON 06/06/2022 1 30 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:82715-101-02 1 in 1 CARTON 06/06/2022 2 30 mL in 1 TUBE; Type 0: Not a Combination Product 3 NDC:82715-101-03 1 in 1 CARTON 06/06/2022 3 30 mL in 1 TUBE; Type 0: Not a Combination Product 4 NDC:82715-101-04 1 in 1 CARTON 06/06/2022 4 30 mL in 1 TUBE; Type 0: Not a Combination Product 5 NDC:82715-101-05 1 in 1 CARTON 06/06/2022 5 30 mL in 1 TUBE; Type 0: Not a Combination Product 6 NDC:82715-101-06 1 in 1 CARTON 06/06/2022 6 30 mL in 1 TUBE; 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 06/06/2022 Labeler - ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (525225637) Establishment Name Address ID/FEI Business Operations ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI 525225637 manufacture(82715-101)