Label: COVERGIRL PLUS OLAY SIMPLY AGELESS FOUNDATION PLUS TITANIUM DIOXIDE SUNSCREEN BROAD SPECTRUM SPF 28 (ALL SHADES)- titanium dioxide cream
- NDC Code(s): 22700-155-12
- Packager: Noxell Corporation
- 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 January 28, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
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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
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Directions
- apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use water resistant sunscreen if swimming or sweating.
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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 sun, especially from 10 a.m. – 2 p.m
- wear long-sleeved shirts, pants, hats, and sunglasses
- children under 6 months: ask a doctor.
- Other information
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Inactive ingredients
Water, cyclopentasiloxane, talc, butylene glycol, niacinamide, euphorbia cerifera (candelilla) wax, isotridecyl isononanoate, ceresin, acetyl glucosamine, silica, peg-9 polydimethylsiloxyethyl dimethicone, sorbitan isostearate, tocopheryl acetate, dimethicone, methicone, panthenol, disodium edta, disodium stearoyl glutamate, stearic acid, hydrogen dimethicone, aluminum hydroxide, phenoxyethanol, hydroxypropyl cyclodextrin, iodopropynyl butylcarbamate.
MAY CONTAIN: Iron oxides, titanium dioxide. - Questions?
- Principal Display Panel - 12 g (0.4 OZ) Jar Label
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INGREDIENTS AND APPEARANCE
COVERGIRL PLUS OLAY SIMPLY AGELESS FOUNDATION PLUS TITANIUM DIOXIDE SUNSCREEN BROAD SPECTRUM SPF 28 (ALL SHADES)
titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:22700-155 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.9 mg in 0.1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) TALC (UNII: 7SEV7J4R1U) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) NIACINAMIDE (UNII: 25X51I8RD4) CANDELILLA WAX (UNII: WL0328HX19) ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT) CERESIN (UNII: Q1LS2UJO3A) N-ACETYLGLUCOSAMINE (UNII: V956696549) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) DIMETHICONE (UNII: 92RU3N3Y1O) PANTHENOL (UNII: WV9CM0O67Z) EDETATE DISODIUM (UNII: 7FLD91C86K) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) PHENOXYETHANOL (UNII: HIE492ZZ3T) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:22700-155-12 12 g in 1 JAR; Type 0: Not a Combination Product 07/06/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/06/2015 Labeler - Noxell Corporation (003082997) Registrant - COTY US LLC (039056361) Establishment Name Address ID/FEI Business Operations Noxell Corporation 003082997 manufacture(22700-155)
