OTC Medication Information: I Conceal Flawless Foundation Broad Spectrum SPF 30 Sunscreen Natural

I CONCEAL FLAWLESS FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN NATURAL- zinc oxide and titanium dioxide cream
Allure Labs 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:

Zinc Oxide — 8.5 %

Titanium Dioxide — 11.7%

Purpose: Sunscreen

Uses:

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

Warning:

  • For external use only.

Do not use:

  • on damaged or broken skin.

When using this products:

  • Keep out of eyes. If contact occurs rinse with water to remove.

Stop use and ask a doctor

  • if skin irritation develops.

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 15 minutes before sun exposer.
  • Children under 6 months of age: ask a doctor.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Sun protection measures. Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease the 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 sleeve shirts, pants, hats and sunglasses.

Inactive Ingredients: Water/Aqua/Eau, Cyclopentasiloxane, Coconut Alkanes, Squalne, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/ Sebacate, Glycerin, Silica, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Isohexadecane, Polyglyceryl-4 Isostearate, Vinyl Dimethicone/Lauryl Dimethicone, Dimethicone, Hydroxypropylcocoate PEG-8 Dimethicone, Alumina, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Tetradecane, Mica, Cyclohexasiloxane, Magnesium Sulfate, Polyhydroxystearic Acid, Triethoxysilyethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Caprylyl Glycol, Dimethicone/PEG-10/15 Crosspolymer, Ethylhexylglycerin, Hexylene Glycol, Dipotassium Glycyrrhizate, Perflurorodecalin, Zinc PCA, Saccharomyces Lysate Extract, Centella Asiatica Extract, Leuconostoc/Radish Root Ferment Filtrate, Olea Europa (Olive) Leaf Extract, Algae Extract, Phospholipids, Artemisia Vulgaris Extract, Hyaluronic Acid, Isomalt, Cyperus Rotundus Root Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Xanthium Sibiricum Fruit Extract, Dipropylene Glycol, Retinyl Palmitate, Tocopherol, Ascorbyl Palmitate, Opuntia Ficus-Indica Stem Extract, Sodium Citrate, Sodium Benzoate, Phenoxyethanol, Potassium Sorbate, Salicylic Acid, Acetyl Hexapeptide-8, Sorbic Acid, Lecithin, Vitis Vinifera (Grape) Fruit Cell Extract, Pantearythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Ergothionine, [+/-: Ci 77163, Ci 77492, Ci 77491, Ci 77499, Beta-carotene].

Manufactured for:

IMAGE Skincare, Lantana, FL 33462 USA

Manufactured in USA from globally

sourced ingredients and components

www.ImageSkincare.com

I Conceal Natural SPF 30
(click image for full-size original)
I CONCEAL FLAWLESS FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN NATURAL
zinc oxide and titanium dioxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4174
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 85 mg in 1 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 117 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
CYCLOMETHICONE 5
COCONUT ALKANES
SQUALANE
GLYCERIN
SILICON DIOXIDE
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)
HEXYL LAURATE
ISOHEXADECANE
POLYGLYCERYL-4 ISOSTEARATE
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
HYDROGEN DIMETHICONE (13 CST)
DIMETHICONE
ALUMINUM OXIDE
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)
TETRADECANE
MICA
CYCLOMETHICONE 6
MAGNESIUM SULFATE, UNSPECIFIED FORM
POLYHYDROXYSTEARIC ACID (2300 MW)
CAPRYLYL GLYCOL
ETHYLHEXYLGLYCERIN
HEXYLENE GLYCOL
GLYCYRRHIZINATE DIPOTASSIUM
PERFLUNAFENE
ZINC PIDOLATE
SACCHAROMYCES LYSATE
CENTELLA ASIATICA
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE
OLEA EUROPAEA LEAF
LAMINARIA DIGITATA
LECITHIN, SOYBEAN
ARTEMISIA VULGARIS WHOLE
HYALURONIC ACID
ISOMALT
CYPERUS ROTUNDUS TUBER
LONICERA JAPONICA FLOWER
XANTHIUM SIBIRICUM FRUIT
DIPROPYLENE GLYCOL
VITAMIN A PALMITATE
TOCOPHEROL
ASCORBYL PALMITATE
OPUNTIA FICUS-INDICA STEM
SODIUM CITRATE
SODIUM BENZOATE
PHENOXYETHANOL
POTASSIUM SORBATE
SALICYLIC ACID
ACETYL HEXAPEPTIDE-8
SORBIC ACID
WINE GRAPE
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)
ERGOTHIONEINE
BISMUTH OXYCHLORIDE
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
BETA CAROTENE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62742-4174-2 1 TUBE in 1 CARTON contains a TUBE (62742-4174-1)
1 NDC:62742-4174-1 28 g in 1 TUBE This package is contained within the CARTON (62742-4174-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 10/04/2019
Labeler — Allure Labs Inc (926831603)

Revised: 10/2019 Allure Labs 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.

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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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