Label: GR HD FOUNDATION HIGH DEFINITION SPF 15- avobenzone, octinoxate lotion
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NDC Code(s):
82715-105-01,
82715-105-02,
82715-105-03,
82715-105-04, view more82715-105-05, 82715-105-06, 82715-105-07, 82715-105-08, 82715-105-09, 82715-105-10
- 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 July 26, 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, Peg-10 Dimethicone, Isononyl Isononanoate, Talc, Dimethicone, Cyclohexasiloxane, Methylpropanediol, Silica, Sodium Chloride, Phenoxyethanol, Dimethicone Crosspolymer, Titanium Dioxide, Tocopheryl Acetate, Triethoxycaprylylsilane, Glycerin, Pentylene Glycol, Disodium Stearoyl Glutamate, Lactic Acid, Serine, Sodium Lactate, Sorbitol, Urea, Isostearyl Sebacate, Aluminum Hydroxide, Fragrance, Magnesium Stearate, Allantoin, Linalool, *Iron Oxides. *contains one or more of these ingredients.
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SPL UNCLASSIFIED SECTION
GOLDEN ROSE
SOFT FOCUS FLAWLESS FINISH
SPF 15
• Blurs imperfections' look
• Medium coverage
• Lightweight & HydratingDERMATOLOGICALLY TESTED
101 PORCELAIN
Manufactured By:
ERKUL COSMETICS San. Tic. A.Ş.,
Petrol Ofisi Cad. No:1
Avcılar, ISTANBUL, TURKIYE,
34310Phone: +90 212 456 53 00
www.goldenrose.com.tr
info@goldenrose.com.trMADE IN TURKIYE
Distributed By:
CELESTY LLC
3970 NW 167TH 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 HD FOUNDATION HIGH DEFINITION SPF 15
avobenzone, octinoxate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82715-105 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.1 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) TALC (UNII: 7SEV7J4R1U) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE 6 (UNII: XHK3U310BA) METHYLPROPANEDIOL (UNII: N8F53B3R4R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOXYETHANOL (UNII: HIE492ZZ3T) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) GLYCERIN (UNII: PDC6A3C0OX) PENTYLENE GLYCOL (UNII: 50C1307PZG) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) SERINE (UNII: 452VLY9402) SODIUM LACTATE (UNII: TU7HW0W0QT) SORBITOL (UNII: 506T60A25R) UREA (UNII: 8W8T17847W) ISOSTEARYL SEBACATE (UNII: S78O3FPG9R) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) MAGNESIUM STEARATE (UNII: 70097M6I30) ALLANTOIN (UNII: 344S277G0Z) LINALOOL, (+/-)- (UNII: D81QY6I88E) 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:82715-105-01 1 in 1 CARTON 07/22/2022 1 30 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:82715-105-02 1 in 1 CARTON 07/22/2022 2 30 mL in 1 TUBE; Type 0: Not a Combination Product 3 NDC:82715-105-03 1 in 1 CARTON 07/22/2022 3 30 mL in 1 TUBE; Type 0: Not a Combination Product 4 NDC:82715-105-04 1 in 1 CARTON 07/22/2022 4 30 mL in 1 TUBE; Type 0: Not a Combination Product 5 NDC:82715-105-05 1 in 1 CARTON 07/22/2022 5 30 mL in 1 TUBE; Type 0: Not a Combination Product 6 NDC:82715-105-06 1 in 1 CARTON 07/22/2022 6 30 mL in 1 TUBE; Type 0: Not a Combination Product 7 NDC:82715-105-07 1 in 1 CARTON 07/22/2022 7 30 mL in 1 TUBE; Type 0: Not a Combination Product 8 NDC:82715-105-08 1 in 1 CARTON 07/22/2022 8 30 mL in 1 TUBE; Type 0: Not a Combination Product 9 NDC:82715-105-09 1 in 1 CARTON 07/22/2022 9 30 mL in 1 TUBE; Type 0: Not a Combination Product 10 NDC:82715-105-10 1 in 1 CARTON 07/22/2022 10 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 07/22/2022 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(82715-105)