OTC Medication Information: MAC PREP AND PRIME FACE PROTECT BROAD SPECTRUM SPF 50

MAC PREP AND PRIME FACE PROTECT BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion
MAKEUP ART COSMETICS

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.

Drug Facts

Active Ingredients Purpose
Avobenzone 3.00% Sunscreen
Homosalate 5.00% Sunscreen
Octisalate 5.00% Sunscreen
Octocrylene 2.70% Sunscreen
Oxybenzone 3.00% 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

inactive ingredients

water\aqua\eau, butyloctyl salicylate, methyl trimethicone, neopentyl glycol diheptanoate, aleurites moluccana (kukui) seed oil, lauryl peg-9 polydimethylsiloxyethyl dimethicone, peg-100 stearate, butylene glycol, glyceryl stearate, dipentaerythrityl tri-polyhydroxystearate, sodium hyaluronate, lavandula angustifolia (lavender) flower water, laminaria ochroleuca extract, laminaria digitata extract, algae extract, caffeine, ethylhexylglycerin, caprylic/capric triglyceride, sorbitol, methyldihydrojasmonate, ergothioneine, dehydroxanthan gum, vp/eicosene copolymer, saccharide isomerate, ammonium acryloyldimethyltaurate/vp copolymer, potassium cetyl phosphate, caprylyl glycol, citric acid, stearic acid, cetyl alcohol, linalool, limonene, disodium edta, phenoxyethanol, sodium dehydroacetate, mica <iln40739>

Other information

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

DIST. BY: MAKE-UP ART COSMETICS
TORONTO, ONTARIO, CANADA M5V 1R7
LONDON W1K 3BQ / MTX7

PRINCIPAL DISPLAY PANEL — 30 ML Tube Carton

M•A•C
PREP+PRIME

FACE PROTECT
LOTION SPF 50
BROAD SPECTRUM
SPF 50

30 ML/1.0 US FL OZ e

PRINCIPAL DISPLAY PANEL -- 30 ML Tube Carton
(click image for full-size original)
MAC PREP AND PRIME FACE PROTECT BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:40046-0063
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 30 mg in 1 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE 50 mg in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 27 mg in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 30 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
BUTYLOCTYL SALICYLATE
METHYL TRIMETHICONE
NEOPENTYL GLYCOL DIHEPTANOATE
KUKUI NUT OIL
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
PEG-100 STEARATE
BUTYLENE GLYCOL
GLYCERYL MONOSTEARATE
DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE
HYALURONATE SODIUM
CAFFEINE
ETHYLHEXYLGLYCERIN
MEDIUM-CHAIN TRIGLYCERIDES
SORBITOL
METHYL DIHYDROJASMONATE (SYNTHETIC)
ERGOTHIONEINE
DEHYDROXANTHAN GUM
SACCHARIDE ISOMERATE
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER
POTASSIUM CETYL PHOSPHATE
CAPRYLYL GLYCOL
CITRIC ACID MONOHYDRATE
STEARIC ACID
CETYL ALCOHOL
LINALOOL, (+/-)-
EDETATE DISODIUM ANHYDROUS
PHENOXYETHANOL
SODIUM DEHYDROACETATE
MICA
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:40046-0063-1 1 TUBE in 1 CARTON contains a TUBE
1 30 mL in 1 TUBE This package is contained within the CARTON (40046-0063-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final M020 02/02/2012
Labeler — MAKEUP ART COSMETICS (010597206)
Registrant — Estee Lauder Companies Inc. (790802086)
Establishment
Name Address ID/FEI Operations
The Estee Lauder Inc 802599436 manufacture (40046-0063), pack (40046-0063), label (40046-0063)

Revised: 08/2023 MAKEUP ART COSMETICS

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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