SLMD UV BOUNCE, SHADE 003- titanium dioxide, zinc oxide powder

United States - English - NLM (National Library of Medicine)

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Active ingredient:
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
Available from:
Skin PS Brands
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Authorization status:
OTC monograph not final
Authorization number:
73318-4319-1

SLMD UV BOUNCE, SHADE 003- titanium dioxide, zinc oxide powder

Skin PS Brands

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.

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SLMD UV Bounce, shade 003

SLMD UV Bounce

SLMD UV BOUNCE, SHADE 003

titanium dioxide, zinc oxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:73318 -4319

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

0 .125 g in 1 g

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

ZINC OXIDE

0 .225 g in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

MICA (UNII: V8 A1AW0 8 8 0 )

TRIETHO XYCAPRYLYLSILANE (UNII: LDC331P0 8 E)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

PO LYMETHYLSILSESQ UIO XANE ( 11 MICRO NS) (UNII: Z570 VEV8 XK)

DIMETHICO NE/VINYL DIMETHICO NE CRO SSPO LYMER ( SO FT PARTICLE) (UNII: 9 E4CO0 W6 C5)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

BUTYLO CTYL SALICYLATE (UNII: 2EH13UN8 D3)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

PRO PANEDIO L (UNII: 59 6 5N8 W8 5T)

PHYSALIS ANGULATA (UNII: W4TKW9 D5GG)

NIACINAMIDE (UNII: 25X51I8 RD4)

ISO DECYL SALICYLATE (UNII: S70 9 7PFP4C)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

Product Characteristics

Color

bro wn

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:73318 -

4319 -1

6 g in 1 BOTTLE, WITH APPLICATOR; Type 0 : No t a Co mbinatio n

Pro duc t

0 7/15/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 7/15/20 19

Labeler -

Skin PS Brands (081085221)

Registrant -

Nanophase T echnologies Corporation (623502044)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Nano phase Techno lo gies Co rpo ratio n

0 50 38 30 46

api manufacture(73318 -4319 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Nano phase Techno lo gies

api manufacture(73318 -4319 ) , manufacture(73318 -4319 ) , pack(73318 -

Skin PS Brands

Nano phase Techno lo gies

Co rpo ra tio n

6 2350 20 44

api manufacture(73318 -4319 ) , manufacture(73318 -4319 ) , pack(73318 -

4319 )

Revised: 7/2019

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