NDC | 43526-113-01, 43526-113-02 |
Set ID | 9838123c-e69a-4f4b-aab5-a07c748600ed |
Category | HUMAN OTC DRUG LABEL |
Packager | Inel Cosmetics Co., Ltd. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
- PURPOSE
-
INSTRUCTIONS FOR USE
Apply liberally 15 minutes before sun exposure
Reapply at least every two 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 broad spectrum SPF of 15 or higher and other sun protection measures including:
Limit time in the sun, especially from 10a.m. - 2p.m.
Wear long-sleeve shirts, pants, hats, and sunglassesChildren under 6 months: Ask a doctor.
For external use only
- KEEP OUT OF REACH OF CHILDREN
- ASK DOCTOR
- WHEN USING
- DO NOT USE
- OTHER SAFETY INFORMATION
-
INACTIVE INGREDIENT
WATER
CYCLOPENTASILOXANE
TALC
GLYCERIN
ISOEICOSANE
PEG-10 DIMETHICONE (600 CST)
MICA
ARBUTIN
DIPROPYLENE GLYCOL
CYCLOMETHICONE
TRIETHYLHEXANOIN
DISTEARDIMONIUM HECTORITE
HEXYL LAURATE
MAGNESIUM SULFATE
FERRIC OXIDE YELLOW
C12-14 PARETH-3
PHENOXYETHANOL
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
METHICONE (20 CST)
PALMITIC ACID
METHYLPARABEN
TOCOPHERYL ACETATE
DIMETHICONE
BETAINE
PROPYLPARABEN
ALUMINUM HYDROXIDE
ADENOSINE
ALUMINUM STEARATE
BUTYLPARABEN
DIMETHICONE
PORK COLLAGEN
CERAMIDE 3
GOLD
PRUNUS SERRULATA FLOWER EXTRACT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MAGIS LENE COLLAGEN CHOC EXTRA GOLD BB CREAM
ethylhexyl methoxycinnamate, titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43526-113 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.5 g in 50 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.305 g in 50 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.96 g in 50 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) TALC (UNII: 7SEV7J4R1U) GLYCERIN (UNII: PDC6A3C0OX) ISOEICOSANE (UNII: AR294KAG3T) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) MICA (UNII: V8A1AW0880) ARBUTIN (UNII: C5INA23HXF) DIPROPYLENE GLYCOL (UNII: E107L85C40) CYCLOMETHICONE (UNII: NMQ347994Z) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) HEXYL LAURATE (UNII: 4CG9F9W01Q) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) C12-14 PARETH-3 (UNII: 93RY22U87E) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) METHICONE (20 CST) (UNII: 6777U11MKT) PALMITIC ACID (UNII: 2V16EO95H1) METHYLPARABEN (UNII: A2I8C7HI9T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) DIMETHICONE (UNII: 92RU3N3Y1O) BETAINE (UNII: 3SCV180C9W) PROPYLPARABEN (UNII: Z8IX2SC1OH) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ADENOSINE (UNII: K72T3FS567) ALUMINUM STEARATE (UNII: U6XF9NP8HM) BUTYLPARABEN (UNII: 3QPI1U3FV8) PORK COLLAGEN (UNII: I8442U2G7J) CERAMIDE 3 (UNII: 4370DF050B) GOLD (UNII: 79Y1949PYO) PRUNUS SERRULATA FLOWER (UNII: 60I4615G0K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43526-113-02 1 in 1 CARTON 01/30/2018 1 NDC:43526-113-01 50 g 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 not final part352 01/30/2018 Labeler - Inel Cosmetics Co., Ltd. (688038939) Registrant - Inel Cosmetics Co., Ltd. (688038939) Establishment Name Address ID/FEI Business Operations Kolmar Korea Co., Ltd. 689512611 manufacture(43526-113)