Garnier Green Labs Brightening Serum PineaC Broad Spectrum SPF 30 Sunscreen: Package Insert and Label Information

GARNIER GREEN LABS BRIGHTENING SERUM PINEAC BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene cream
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 ingredient

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7.2%

Purpose

Sunscreen

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

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 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, glycerin, silica, dimethicone, PEG-100 stearate, glyceryl stearate, ammonium polyacryloyldimethyl taurate, stearic acid, phenoxyethanol, palmitic acid, PEG-32, ascorbyl glucoside, dicaprylyl carbonate, steareth-100, propanediol, phenylethyl resorcinol, capryloyl salicylic acid, caprylyl glycol, xanthan gum, dimethicone/vinyl dimethicone crosspolymer, fragrance, disodium EDTA, tocopherol, sodium hyaluronate, sodium hydroxide, myristic acid, ananas sativus (pineapple) fruit extract, papain

Questions or comments?

1-800-370-1925

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GARNIER GREEN LABS BRIGHTENING SERUM PINEAC BROAD SPECTRUM SPF 30 SUNSCREEN
avobenzone, homosalate, octisalate and octocrylene cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-313
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 72 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
SILICON DIOXIDE
DIMETHICONE
PEG-100 STEARATE
GLYCERYL MONOSTEARATE
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S)
STEARIC ACID
PHENOXYETHANOL
PALMITIC ACID
POLYETHYLENE GLYCOL 1600
ASCORBYL GLUCOSIDE
DICAPRYLYL CARBONATE
STEARETH-100
PROPANEDIOL
PHENYLETHYL RESORCINOL
CAPRYLOYL SALICYLIC ACID
CAPRYLYL GLYCOL
XANTHAN GUM
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
EDETATE DISODIUM
TOCOPHEROL
HYALURONATE SODIUM
SODIUM HYDROXIDE
MYRISTIC ACID
PINEAPPLE
PAPAIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49967-313-01 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
1 72 mL in 1 BOTTLE, PUMP This package is contained within the CARTON (49967-313-01)
2 NDC:49967-313-02 1.5 mL in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 08/01/2020
Labeler — L’Oreal USA Products Inc (002136794)
Establishment
Name Address ID/FEI Operations
L’Oreal USA, Inc. 624244349 manufacture (49967-313)

Revised: 02/2022 L’Oreal USA Products Inc

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