MILANI PRIME PROTECT SPF 30 FACE PRIMER- avobenzone, octinoxate, octocrylene, and oxybenzone cream

Milani Prime Protect SPF 30 Face Primer by

Drug Labeling and Warnings

Milani Prime Protect SPF 30 Face Primer by is a Otc medication manufactured, distributed, or labeled by The Milani Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Avobenzone 3.0%	Sunscreen
Octinoxate 7.3%	Sunscreen
Octocrylene 3.0%	Sunscreen
Oxybenzone 2.0%	Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection (see Directions), decreases the risk of skin cancer and early skin aging caused by sun

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

For Sunscreen use:

• Apply generously and evenly 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water-resistant sunscreen if swimming or sweating
• Sun Protection Measures. Spending time in 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, and sun glasses
  • Children under 6 months of age: Ask a doctor.

Other information

• Protect the product in this container from excessive heat and direct sun

Inactive Ingredients

water, glycerin, isohexadecane, sodium acrylate/sodium acryloyldimethyl taurate copolymer, PEG-8, phenoxyethanol, polysorbate 80, xanthan gum, tocopherol, ethylhexylglycerin, citric acid, retinyl palmitate, disodium EDTA, glycine soja (soybean) oil, yellow 5 (CI 19140), red 40 (CI 16035).

Questions or comments?

Call 866–789–8002 Monday – Friday (8 a.m. to 5 p.m. PST)

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

MILANI

PRIME
PROTECT

SPF 30 FACE PRIMER

BROAD SPECTRUM SUNSCREEN
+ UVA/UVB PROTECTION

1 FL OZ / 30 mL

INGREDIENTS AND APPEARANCE

MILANI PRIME PROTECT SPF 30 FACE PRIMER 
avobenzone, octinoxate, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71435-8202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	73 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	30 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Isohexadecane (UNII: 918X1OUF1E)
Sodium Acrylate/Sodium Acryloyldimethyltaurate Copolymer (4000000 MW) (UNII: 1DXE3F3OZX)
PEG-8 Stearate (UNII: 2P9L47VI5E)
Phenoxyethanol (UNII: HIE492ZZ3T)
Polysorbate 80 (UNII: 6OZP39ZG8H)
XANTHAN GUM (UNII: TTV12P4NEE)
Tocopherol (UNII: R0ZB2556P8)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SOYBEAN OIL (UNII: 241ATL177A)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71435-8202-6	1 in 1 CARTON	11/25/2017
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	11/25/2017

Labeler - The Milani Group, Inc. (120923342)

Establishment
Name	Address	ID/FEI	Business Operations
Northwest Cosmetic Laboratories LLC		929572014	MANUFACTURE(71435-8202)