PREP AND PRIME FIX PLUS SPF 30 BROAD SPECTRUM SUN- avobenzone, homosalate, octinoxate, octisalate, and octocrylene spray

PREP AND PRIME FIX PLUS SPF 30 BROAD SPECTRUM SUN by

Drug Labeling and Warnings

PREP AND PRIME FIX PLUS SPF 30 BROAD SPECTRUM SUN by is a Otc medication manufactured, distributed, or labeled by MAKEUP ART COSMETICS, 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.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Avobenzone 3.0%	Sunscreen
Homosalate 4.0%	Sunscreen
Octinoxate 6.0%	Sunscreen
Octisalate 3.0%	Sunscreen
Octocrylene 2.0%	Sunscreen

Use

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 15 minutes before sun exposure
• reapply 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 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

Shake very well before use – allowing for SPF and Powder ingredients to be evenly emulsified and distributed.

With eyes and mouth completely closed, mist face evenly while holding bottle 10-12 inches away from face.

Can be used before makeup and after makeup application.

Inactive ingredients

alcohol denat., caprylic/capric triglyceride, methyl methacrylate crosspolymer, polypropylene, butyloctyl salicylate, pvp/hexadecene copolymer, dicaprylyl carbonate, isododecane, fragrance (parfum), citral, geraniol, limonene, linalool <iln45848>

Other Information

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

PRINCIPAL DISPLAY PANEL - 100 ML Bottle Carton

MAC
PREP+PRIME

fix+
spf30

FIX+
SPF 30 SUN SPRAY
BROAD SPECTRUM SPF 30

3.4 FL. OZ. LIQ./100 ML e

INGREDIENTS AND APPEARANCE

PREP AND PRIME FIX PLUS SPF 30 BROAD SPECTRUM SUN 
avobenzone, homosalate, octinoxate, octisalate, and octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40046-0080
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
avobenzone (UNII: G63QQF2NOX) (avobenzone - UNII:G63QQF2NOX)	avobenzone	0.03 g  in 1 mL
homosalate (UNII: V06SV4M95S) (homosalate - UNII:V06SV4M95S)	homosalate	0.04 g  in 1 mL
octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51)	octinoxate	0.06 g  in 1 mL
octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W)	octisalate	0.03 g  in 1 mL
octocrylene (UNII: 5A68WGF6WM) (octocrylene - UNII:5A68WGF6WM)	octocrylene	0.02 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
alcohol (UNII: 3K9958V90M)
medium-chain triglycerides (UNII: C9H2L21V7U)
methyl methacrylate/glycol dimethacrylate crosspolymer (UNII: 657L0NC5MT)
butyloctyl salicylate (UNII: 2EH13UN8D3)
dicaprylyl carbonate (UNII: 609A3V1SUA)
isododecane (UNII: A8289P68Y2)
citral (UNII: T7EU0O9VPP)
geraniol (UNII: L837108USY)
limonene, (+)- (UNII: GFD7C86Q1W)
linalool, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40046-0080-1	1 in 1 CARTON	07/01/2019
1		100 mL in 1 BOTTLE; 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	07/01/2019

Labeler - MAKEUP ART COSMETICS (010597206)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(40046-0080) , REPACK(40046-0080)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(40046-0080)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(40046-0080)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(40046-0080)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(40046-0080)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(40046-0080) , REPACK(40046-0080)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(40046-0080) , REPACK(40046-0080)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(40046-0080)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(40046-0080)