OTC Medication Information: Illusion Tinted Moisturizer Broad Spectrum Golden SPF 15

ILLUSION TINTED MOISTURIZER BROAD SPECTRUM GOLDEN SPF 15- octinoxate, octisalate and titanium dioxide emulsion
Kingdom Animalia, LLC DBA Hourglass 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.

Active Ingredients

Octinoxate 7.0%

Octisalate 4.0%

Titanium Dioxide 4.0%

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

Directions

  • Apply liberally 15 minutes before sun exposure.
  • 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 of 15 or higher and other skin protection measures including:

  • Limit time in the sun, especially from 10 a.m. – 2 p.m.
  • Wear long-sleeve shirts, pants, hats and sunglasses.

Children under 6 months: Ask a doctor

Inactive Ingredients

ALUMINA, BUTYLENE GLYCOL, CALCIUM CARBONATE, CAPRYLYL GLYCOL, CETYL PEG/PPG 10/1 DIMETHICONE, ETHYLHEXYL PALMITATE, ETHYLHEXYLGLYCERIN, GLYCERIN, GLYCERYL BEHENATE, GLYCERYL DIBEHENATE, GOSSYPIUM HERBACEUM(COTTON), HEXYL LAURATE, HEXYLENE GLYCOL, HYDROGENATED POLYISOBUTENE, LYCIUM BARBARUM FRUIT EXTRACT, MAGNESIUM SULFATE, MICA, MICROCRYSTALLINE WAX, PEG-10 DIMETHICONE, PENTAERYTHRITYL, TETRASISOSTERATE, PHENOXYETHANOL, POLYETHYLACRYLATE, POLYGLYCERYL-3 BEESWAX, POLYGLYCERYL-3 POLYRICINOLEATE, POLYGLYCERYL-4 ISOSTEARATE, POTASSIUM SORBATE, PROPYLENE CARBONATE, QUATERNIUM-90 BENTONITE, SILICA, SILICA DIMETHYL SILYLATE, SODIUM BENZOATE, SODIUM CHLORIDE, SODIUM HYALURONATE, STEARIC ACID, TREBEHENIN, TRIETHOXYLCAPRYLYLSILANE, WATER. MAY CONTAIN (+/-): IRON OXIDES (CI77491), IRON OXIDES (CI77492), IRON OXIDES (CI77499), TITANIUM DIOXIDE (CI77891).

Other information

Protect this product from excessive heat and direct sun.

Questions or Comments?

Call toll free 855-201-4529

ILLUC
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ILLUSION TINTED MOISTURIZER BROAD SPECTRUM GOLDEN SPF 15
octinoxate, octisalate, titanium dioxide emulsion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42627-264
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 7 g in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE 4 g in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 4 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
MAGNESIUM SULFATE, UNSPECIFIED
GLYCERIN
SODIUM BENZOATE
POTASSIUM SORBATE
LYCIUM BARBARUM FRUIT
PHENOXYETHANOL
CAPRYLYL GLYCOL
HEXYLENE GLYCOL
CALCIUM CARBONATE
POLYGLYCERYL-3 RICINOLEATE
GLYCERYL DIBEHENATE
TRIBEHENIN
MICROCRYSTALLINE WAX
PROPYLENE CARBONATE
HEXYL LAURATE
PEG-10 DIMETHICONE (600 CST)
POLYGLYCERYL-4 ISOSTEARATE
STEARIC ACID
ALUMINUM OXIDE
GOSSYPIUM HERBACEUM WHOLE
DIMETHICONE
MICA
SILICON DIOXIDE
PENTAERYTHRITYL TETRAISOSTEARATE
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
TRIETHOXYCAPRYLYLSILANE
HYDROGENATED POLYBUTENE (1300 MW)
ETHYLHEXYLGLYCERIN
ETHYLHEXYL PALMITATE
SILICA DIMETHYL SILYLATE
BUTYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42627-264-02 1 TUBE in 1 CARTON contains a TUBE (42627-264-01)
1 NDC:42627-264-01 30 mL in 1 TUBE This package is contained within the CARTON (42627-264-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/01/2014
Labeler — Kingdom Animalia, LLC DBA Hourglass Cosmetics (004924553)

Revised: 10/2022 Kingdom Animalia, LLC DBA Hourglass 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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