Label: GR NUDE LOOK SPF 25- avobenzone, octinoxate cream
- NDC Code(s): 82715-103-01, 82715-103-02, 82715-103-03
- 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 23, 2022
If you are a consumer or patient please visit this version.
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- 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), Diphenylsiloxy Phenyl Trimethicone, Caprylyl Methicone, Dimethicone, Butylene Glycol, Glycerin, Bellis Perennis (Daisy) Flower Extract, Peg-9 Polydimethylsiloxyethyl Dimethicone, Phenoxyethanol, Acrylates/Dimethicone Copolymer, Dimethicone/Peg-10/15 Crosspolymer, Magnesium Sulfate, Tocopheryl Acetate, Linoleic Acid, Titanium Dioxide, Peg-8, Sodium Chloride, Pentylene Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Aluminum Hydroxide, Tocopherol, Lactic acid, Fragrance, Serine, Sodium Lactate, Sorbitol, Urea, Ethylhexylglycerin, Disodium Edta, Sodium Hyaluronate, Alumina, Stearic Acid, Ascorbyl Palmitate, Dipropylene Glycol, Potassium Sorbate, Sodium Citrate, Ascorbic Acid, Citric Acid, Linolenic Acid, Allantoin, Disodium Phosphate. *Iron Oxides.
*contains one or more of these ingredients. -
SPL UNCLASSIFIED SECTION
GOLDEN ROSE
RADIANT TINTED MOISTURISER
HYDRATING SKIN TINT
Broad Spectrum SPF 25
01 FAIR TINT
02 MEDIUM TINT
03 DEEP TINT
• Radiant tinted moisturiser gives a healthy and fresh looking for the "no make-up look".
• The advanced non oily formula infused with hydrating complex and vitamins.
• SPF 25 sun protection shields your skin from the sun's harmful rays.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 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 NUDE LOOK SPF 25
avobenzone, octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82715-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.25 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) BELLIS PERENNIS FLOWER (UNII: 26I94X9A1K) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) PHENOXYETHANOL (UNII: HIE492ZZ3T) 2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M) DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LINOLEIC ACID (UNII: 9KJL21T0QJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SODIUM CHLORIDE (UNII: 451W47IQ8X) PENTYLENE GLYCOL (UNII: 50C1307PZG) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) TOCOPHEROL (UNII: R0ZB2556P8) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) SERINE (UNII: 452VLY9402) SODIUM LACTATE (UNII: TU7HW0W0QT) SORBITOL (UNII: 506T60A25R) UREA (UNII: 8W8T17847W) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ALUMINUM OXIDE (UNII: LMI26O6933) STEARIC ACID (UNII: 4ELV7Z65AP) ASCORBYL PALMITATE (UNII: QN83US2B0N) DIPROPYLENE GLYCOL (UNII: E107L85C40) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) ASCORBIC ACID (UNII: PQ6CK8PD0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) LINOLENIC ACID (UNII: 0RBV727H71) ALLANTOIN (UNII: 344S277G0Z) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) 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:82715-103-01 1 in 1 CARTON 07/22/2022 1 32 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:82715-103-02 1 in 1 CARTON 07/22/2022 2 32 mL in 1 TUBE; Type 0: Not a Combination Product 3 NDC:82715-103-03 1 in 1 CARTON 07/22/2022 3 32 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(82715-103)