OTC Medication Information: LOreal Paris Revitalift Derm Intensives Invisible UV Fluid Broad Spectrum SPF 50 Sunscreen

LOREAL PARIS REVITALIFT DERM INTENSIVES INVISIBLE UV FLUID BROAD SPECTRUM SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene gel
L’Oreal USA Products Inc

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.

Active ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Uses

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

Warnings

For external use only

Flammable until dry.

Do not use near fire, flame, or heat.

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:

  • shake well
  • apply liberally 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 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

Other information

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

Inactive ingredients

water, alcohol denat., glycerin, styrene/acrylates copolymer dimethicone, butyloctyl salicylate, sodium dodecylbenzenesulfonate, phenoxyethanol, phenylethyl resorcinol, adenosine, PEG-8 laurate, PEG-20, trisodium ethylenediamine disuccinate, sclerotium gum, pullulan, ammonium acryloyldimethyltaurate/vp copolymer, xanthan gum, isocetyl stearate, caprylyl glycol, carbomer, cetearyl glucoside, inulin lauryl carbamate

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LOREAL PARIS REVITALIFT DERM INTENSIVES INVISIBLE UV FLUID BROAD SPECTRUM SPF 50 SUNSCREEN
avobenzone, homosalate, octisalate, and octocrylene gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-011
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 150 mg in 1 mL
Octisalate (Octisalate) Octisalate 50 mg in 1 mL
Octocrylene (Octocrylene) Octocrylene 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
GLYCERIN
DIMETHICONE
BUTYLOCTYL SALICYLATE
SILICON DIOXIDE
ISONONYL ISONONANOATE
ISOPROPYL MYRISTATE
CETOSTEARYL ALCOHOL
CALCIUM ALUMINUM BOROSILICATE
TOCOPHEROL
TERT-BUTYL ALCOHOL
ASCORBYL GLUCOSIDE
HYDROGENATED SOYBEAN LECITHIN
SODIUM STEAROYL GLUTAMATE
SODIUM DODECYLBENZENESULFONATE
PHENOXYETHANOL
PHENYLETHYL RESORCINOL
ADENOSINE
PEG-8 LAURATE
POLYETHYLENE GLYCOL 1000
TRISODIUM ETHYLENEDIAMINE DISUCCINATE
BETASIZOFIRAN
PULLULAN
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER
XANTHAN GUM
ISOCETYL STEARATE
CAPRYLYL GLYCOL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
CETEARYL GLUCOSIDE
INULIN LAURYL CARBAMATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49967-011-01 1 BOTTLE in 1 CARTON contains a BOTTLE
1 50 mL in 1 BOTTLE This package is contained within the CARTON (49967-011-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 09/30/2022
Labeler — L’Oreal USA Products Inc (002136794)
Establishment
Name Address ID/FEI Operations
Beauty Manufacturing Solutions Corp. 783200723 manufacture (49967-011), pack (49967-011)

Revised: 09/2022 L’Oreal USA Products Inc

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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