GR TOTAL COVER 2 IN 1 FOUNDATION AND CONCEALER SPF 15- octinoxate lotion

GR TOTAL COVER 2 in 1 Foundation and Concealer SPF 15 by

Drug Labeling and Warnings

GR TOTAL COVER 2 in 1 Foundation and Concealer SPF 15 by is a Otc medication manufactured, distributed, or labeled by ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Octinoxate 1% w/v

Purpose

Sunscreen

Uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

• Do not use on damaged or broken skin: When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

protect the product in this container from excessive heat and direct sun. store at room temperatures: 15°C- 30°C.

Inactive ingredients

Water (Aqua), Cyclopentasiloxane, Dimethicone, Peg-10 Dimethicone, Phenyl Trimethicone, Peg-9 Polydimethylsiloxyethyl Dimethicone, Polymethylsilsesquioxane/Trimethylsiloxysilicate, Caprylyl Methicone, Trımethylsiloxysilicate, Propylene Glycol, Silica Dimethyl Silylate, Disteardimonium Hectorite, Dimethicone/Vinyl Dimethicone Crosspolymer, Polypropylsılsesquioxane, Sodıum Chloride, Zinc Pca, Phenoxyethanol, Silica, Dimethicone Crosspolymer, Peg-12 Dimethicone/Ppg-20 Crosspolymer, Tocopheryl Acetate, Peg/Ppg-18/18 Dimethicone, Talc, Isododecane, Xanthan Gum, Triethoxycaprylylsilane, Titanium Dioxide, Ethylhexylglycerın, Disodium Edta, Isoceteth-10, Fragrance, Magnesium Stearate, Aluminum Hydroxide, Linalool. * Iron Oxides. *contains one or more of these ingredients.

SPL UNCLASSIFIED SECTION

SPF 15

Vitamin E

01 PORCELAIN

Full Coverage & Longwear
Semi-Matte & Smooth Finish
Lightweight/Non-Oily Formula

DERMATOLOGICALLY TESTED

ERKUL KOZMETIK San. Tic. A.Ş.,
P.Ofisi Cd. No:1 Avcılar, IST./TURKEY

MADE IN TURKEY

EU R.P: Platin Beauty Consulting UG
(haftungsbeschränkt)
Bardowicker Str. 6,
21335 Lüneburg/GERMANY

Packaging

INGREDIENTS AND APPEARANCE

GR TOTAL COVER 2 IN 1 FOUNDATION AND CONCEALER SPF 15 
octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82715-106
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATE (UNII: X2PZH4Y6HT)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED (UNII: 2PDG9JR76G)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ZINC PIDOLATE (UNII: C32PQ86DH4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER (UNII: 965K72OQXO)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
TALC (UNII: 7SEV7J4R1U)
ISODODECANE (UNII: A8289P68Y2)
XANTHAN GUM (UNII: TTV12P4NEE)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ISOCETETH-10 (UNII: 1K92T9919H)
MAGNESIUM STEARATE (UNII: 70097M6I30)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
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: 82715-106-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	07/22/2022
2	NDC: 82715-106-02	30 mL in 1 TUBE; Type 0: Not a Combination Product	07/22/2022
3	NDC: 82715-106-03	30 mL in 1 TUBE; Type 0: Not a Combination Product	07/22/2022
4	NDC: 82715-106-04	30 mL in 1 TUBE; Type 0: Not a Combination Product	07/22/2022
5	NDC: 82715-106-05	30 mL in 1 TUBE; Type 0: Not a Combination Product	07/22/2022
6	NDC: 82715-106-06	30 mL in 1 TUBE; Type 0: Not a Combination Product	07/22/2022
7	NDC: 82715-106-07	30 mL in 1 TUBE; Type 0: Not a Combination Product	07/22/2022
8	NDC: 82715-106-08	30 mL in 1 TUBE; Type 0: Not a Combination Product	07/22/2022
9	NDC: 82715-106-09	30 mL in 1 TUBE; Type 0: Not a Combination Product	07/22/2022
10	NDC: 82715-106-10	30 mL in 1 TUBE; Type 0: Not a Combination Product	07/22/2022
11	NDC: 82715-106-11	30 mL in 1 TUBE; Type 0: Not a Combination Product	07/22/2022
12	NDC: 82715-106-12	30 mL in 1 TUBE; Type 0: Not a Combination Product	07/22/2022
13	NDC: 82715-106-13	30 mL in 1 TUBE; Type 0: Not a Combination Product	07/22/2022
14	NDC: 82715-106-14	30 mL in 1 TUBE; Type 0: Not a Combination Product	07/22/2022
15	NDC: 82715-106-15	30 mL in 1 TUBE; Type 0: Not a Combination Product	07/22/2022
16	NDC: 82715-106-16	30 mL in 1 TUBE; Type 0: Not a Combination Product	07/22/2022
17	NDC: 82715-106-17	30 mL in 1 TUBE; Type 0: Not a Combination Product	07/22/2022
18	NDC: 82715-106-18	30 mL in 1 TUBE; Type 0: Not a Combination Product	07/22/2022
19	NDC: 82715-106-19	30 mL in 1 TUBE; Type 0: Not a Combination Product	07/22/2022
20	NDC: 82715-106-20	30 mL in 1 TUBE; Type 0: Not a Combination Product	07/22/2022
21	NDC: 82715-106-21	30 mL in 1 TUBE; Type 0: Not a Combination Product	07/22/2022
22	NDC: 82715-106-22	30 mL in 1 TUBE; Type 0: Not a Combination Product	07/22/2022
23	NDC: 82715-106-23	30 mL in 1 TUBE; Type 0: Not a Combination Product	07/22/2022
24	NDC: 82715-106-24	30 mL in 1 TUBE; Type 0: Not a Combination Product	07/22/2022
25	NDC: 82715-106-25	30 mL in 1 TUBE; Type 0: Not a Combination Product	07/22/2022

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(82715-106)