PHOTO FINISH PROTECT BROAD SPECTRUM SPF 45 PRIMER- avobenzone, homosalate, octinoxate, octisalate, and octocrylene cream

PHOTO FINISH PROTECT BROAD SPECTRUM SPF 45 PRIMER by

Drug Labeling and Warnings

PHOTO FINISH PROTECT BROAD SPECTRUM SPF 45 PRIMER by is a Otc medication manufactured, distributed, or labeled by SMASHBOX BEAUTY COSMETICS, INC, ESTEE LAUDER COMPANY, THE, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTHTEC INC, PADC 1, WHITMAN LABORATORIES, LTD., Kolmar Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Avobenzone 3.0%
Homosalate 10.0%
Octinoxate 7.0%
Octisalate 4.0%
Octocrylene 8.0%

Purpose

Sunscreen

Uses

helps prevent sunburn

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.

Stop use and ask a doctor if rash occurs

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

Directions

For sunscreen use:

• apply liberally and evenly 15 minutes before sun exposure
• apply to all skin exposed to the sun
• 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 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

Inactive Ingredients

Dimethicone, Polymethylsilsesquioxane/Silica Crosspolymer, Talc, Stearyl Dimethicone, Polysilicone-11, Butyloctyl Salicylate, Silica, Dimethiconol, BHT, Phenoxyethanol, Mica <ILN46784>

Other information

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

smashbox

PHOTO FINISH

PROTECT
BROAD SPECTRUM
SPF 45

PRIMER

1 fl. oz. liq. / 30 ml e

INGREDIENTS AND APPEARANCE

PHOTO FINISH PROTECT BROAD SPECTRUM SPF 45 PRIMER 
avobenzone, homosalate, octinoxate, octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10348-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.0303 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.101 g  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.0707 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0404 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.0808 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Dimethicone (UNII: 92RU3N3Y1O)
Talc (UNII: 7SEV7J4R1U)
Stearyl Dimethicone (400 MPA.S at 50C) (UNII: R327X197HY)
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Phenoxyethanol (UNII: HIE492ZZ3T)
Mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10348-017-01	1 in 1 CARTON	11/15/2019
1		30 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	11/15/2019

Labeler - SMASHBOX BEAUTY COSMETICS, INC (945344414)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(10348-017) , REPACK(10348-017)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(10348-017)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(10348-017)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(10348-017)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(10348-017)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(10348-017) , REPACK(10348-017)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(10348-017) , REPACK(10348-017)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(10348-017)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(10348-017)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Laboratories, Inc.		001535103	MANUFACTURE(10348-017)