Label: ILLUMINATING DAILY MOISTURIZER- avobenzone, octisalate and octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 36800-339-19 - Packager: Topco Associates LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated May 11, 2012
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- Active ingredient
- Purpose
- Uses
- Warnings
- Do not use on
- When using this product
- Stop use and ask a doctor
- Keep Out of Reach of Children.
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Directions
- Apply liberally 15 minutes before sun exposure.
- Children under 6 months of age: ask a doctor
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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
- Other Information
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Inactive ingredients
water, C12-15 alkyl benzoate, arachidyl alcohol, behenyl alcohol, arachidyl glucoside, cetearyl alcohol, cetearyl glucoside, steareth-2, glycerin, steareth-21, dimethicone, phenyl trimethicone, polyacrylamide, C13-14 isoparaffin, laureth-7, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, panthenol, polymethyl methacrylate, lecithin, soy isoflavones, polysorbate 80, alcohol, benzyl alcohol, disodium EDTA, fragrance, benzalkonium chloride, BHT, triethanolamine
- Questions?
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Package/Label Principal Display Panel
TopCare® Illuminating Daily Moisturizer
Broad Spectrum SPF15 SunscreenClinically proven
Evens out skin tone and texture with an exclusive soy complex and light diffusers*compare to Aveeno® Positively RadiantTM
4 FL OZ (120 mL)
DISTRIBUTED BY TOPCO ASSOCIATES LLC
7711 GROSS POINT ROAD SKOKIE, IL 60077
©TOPCO PER1109
QUESTIONS? 1-888-423-0139
topcare@topco.comManufactured in Israel
52326 88 C2Carton Label
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INGREDIENTS AND APPEARANCE
ILLUMINATING DAILY MOISTURIZER
avobenzone, octisalate and octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-339 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 mL in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mL in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 8 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) DOCOSANOL (UNII: 9G1OE216XY) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) STEARETH-2 (UNII: V56DFE46J5) GLYCERIN (UNII: PDC6A3C0OX) STEARETH-21 (UNII: 53J3F32P58) DIMETHICONE (UNII: 92RU3N3Y1O) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) BUTYLPARABEN (UNII: 3QPI1U3FV8) PROPYLPARABEN (UNII: Z8IX2SC1OH) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) PANTHENOL (UNII: WV9CM0O67Z) POLY(METHYL ACRYLATE-CO-METHYL METHACRYLATE-CO-METHACRYLIC ACID 7:3:1; 280000 MW) (UNII: 99Q3C7L77T) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SOY ISOFLAVONES (UNII: 71B37NR06D) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALCOHOL (UNII: 3K9958V90M) BENZYL ALCOHOL (UNII: LKG8494WBH) EDETATE DISODIUM (UNII: 7FLD91C86K) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-339-19 1 in 1 CARTON 1 120 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/11/2012 Labeler - Topco Associates LLC (006935977)