BE BEAUTIFUL PURE MAKE UP BASE PURPLE- octinoxate, homosalate, octisalate, octocrylene cream

Be Beautiful Pure Make Up Base Purple by

Drug Labeling and Warnings

Be Beautiful Pure Make Up Base Purple by is a Otc medication manufactured, distributed, or labeled by THANK YOU FARMER CO., LTD., Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Octinoxate 6.00% …………………………………Sunscreen
Titanium Dioxide 4.02% ..………………..……Sunscreen
Octisalate 2.00% ……………………....…………Sunscreen
Zinc Oxide 1.92% ………………………………….Sunscreen

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours

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 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses

Ask a doctor to use for children under 6 months

WARNINGS

For external use only

Do not use on damaged or broken skin

Stop using and ask a doctor if rash occurs

When using this product, keep out of eyes. Rinse with water to remove

KEEP OUT OF REACH OF CHILDREN

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

INACTIVE INGREDIENT

WATER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, PHENYL TRIMETHICONE, ISOEICOSANE, CAPRYLYL METHICONE, PEG-10 DIMETHICONE, DIMETHICONE, NIACINAMIDE, ULTRAMARINES (CI 77007), DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, DIMETHICONE CROSSPOLYMER, TALC, C12-14 PARETH-3, PHENOXYETHANOL, FRAGRANCE, PALMITIC ACID, ALUMINUM HYDROXIDE, ALUMINUM STEARATE, METHICONE, ETHYLHEXYLGLYCERIN, TOCOPHERYL ACETATE, OCTYLDODECANOL, ADENOSINE, SODIUM HYALURONATE, ECHIUM PLANTAGINEUM SEED OIL, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, TOCOPHEROL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BE BEAUTIFUL PURE MAKE UP BASE PURPLE 
octinoxate, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70618-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.4 mg  in 40 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.608 mg  in 40 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.8 mg  in 40 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.768 mg  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
ISOEICOSANE (UNII: AR294KAG3T)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIMETHICONE (UNII: 92RU3N3Y1O)
NIACINAMIDE (UNII: 25X51I8RD4)
ULTRAMARINE BLUE (UNII: I39WR998BI)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
TALC (UNII: 7SEV7J4R1U)
C12-14 PARETH-3 (UNII: 93RY22U87E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PALMITIC ACID (UNII: 2V16EO95H1)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
METHICONE (20 CST) (UNII: 6777U11MKT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OCTYLDODECANOL (UNII: 461N1O614Y)
ADENOSINE (UNII: K72T3FS567)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70618-008-02	1 in 1 CARTON	11/01/2018
1	NDC: 70618-008-01	40 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 not final	part352	11/01/2018

Labeler - THANK YOU FARMER CO., LTD. (689605142)

Registrant - THANK YOU FARMER CO., LTD. (689605142)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	manufacture(70618-008)