MINERALIZED LOOSE POWDER SPF 15- titanium dioxide, ethylhexyl methoxycinnamate powder

Mineralized Loose Powder SPF 15 by

Drug Labeling and Warnings

Mineralized Loose Powder SPF 15 by is a Otc medication manufactured, distributed, or labeled by Modern Beauty Limited, Guangzhou Zilin Cosmetic Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium Dioxide 7.12%

Ethylhexyl Methoxycinnamate 2%

Purpose

Sunscreen

KEEP OUT OF REACH OF CHILDREN

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

Use

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.

Remove with water and mild cleanser

Stop use and ask a doctor if rash occurs.

Directions

apply liberally 15 minutes before sun exposure
reapply:
   after 40 minutes of swimming or sweating
   immediately after towel drying
   at least every 2 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 value of 15 or higher and other sun 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.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: MICA, MAGNESIUM MYRISTATE, NYLON-12, SILICA, DIMETHICONE, SIMMONDSIA CHINENSIS(JOJOBA)SEED OIL, BORON NITRIDE, PHENOXYETHANOL, METHYLPARABEN, BUTYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, ISOBUTYLPARABEN, BHT, MAY CONTAIN:[YELLOW IRON OXIDE(CI77492), RED IRON OXIDE(CI77491), BLACK IRON OXIDE(CI77499), FD&C RED 40 AL LAKE(CI16035), FD&C YELLOW 5 AL LAKE(CI19140:1), FD&C YELLOW 6 AL LAKE(CI15985:1)]

Other Information

Protect this product from excessive heat and direct sun

Questions

Call toll free 1-877-438-1120

SPL UNCLASSIFIED SECTION

FORMULATED FOR PROFESSIONAL APPLICATION

THIS CARTON IS MADE FROM RECYCLED PAPER

CRUELTY FREE - THIS PRODUCT HAS NEVER BEEN TESTED ON ANIMALS.

MADE IN CHINA

MODERN BASIC,BURNABY CANADA/GARDEN GROVE CA.

Packaging

INGREDIENTS AND APPEARANCE

MINERALIZED LOOSE POWDER SPF 15 
titanium dioxide, ethylhexyl methoxycinnamate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69349-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7.12 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
JOJOBA OIL (UNII: 724GKU717M)
BORON NITRIDE (UNII: 2U4T60A6YD)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69349-102-33	1 in 1 CARTON	12/05/2015
1		15 g in 1 CONTAINER; 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	12/05/2015

Labeler - Modern Beauty Limited (009651789)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Zilin Cosmetic Co., Ltd.		421050876	manufacture(69349-102)