Label: DOUBLE WEAR MAXIMUM COVER CAMOUFLAGE MAKEUP FOR FACE AND BODY BROAD SPECTRUM SPF 15- titanium dioxide cream
- NDC Code(s): 11559-030-01
- Packager: ESTEE LAUDER INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 July 6, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
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Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- reapply at least every two hours
- use a 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 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-sleeved shirts, pants, hats and sunglasses
- children under 6 months of age: ask a doctor
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Inactive ingredients
isododecane•isohexadecane•methyl methacrylate crosspolymer•petrolatum•glyceryl stearate•disteardimonium hectorite•hydrogenated styrene/isoprene copolymer•microcrystalline wax\cera microcristallina\cire microcristalline•kaolin•cholesterol•aloe barbadensis leaf extract•fusanus spicatus wood oil•tocopheryl acetate•linoleic acid•glycine soja (soybean) oil•stearyl glycyrrhetinate•bisabolol•silica•propylene carbonate•methyldihydrojasmonate•polyethylene•2,6-dimethyl-7-octen-2-ol•polyglyceryl-3 diisostearate•pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate• alumina•phenethyl alcohol•[+/- iron oxides (ci 77491)•iron oxides (ci 77492)•iron oxides (ci 77499)•titanium dioxide (ci 77891)•mica•bismuth oxychloride (ci 77163)] <iln40794>
- Other information
- PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton
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INGREDIENTS AND APPEARANCE
DOUBLE WEAR MAXIMUM COVER CAMOUFLAGE MAKEUP FOR FACE AND BODY BROAD SPECTRUM SPF 15
titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-030 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 14 mg in 1 mL Inactive Ingredients Ingredient Name Strength FARNESOL (UNII: EB41QIU6JL) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ISODODECANE (UNII: A8289P68Y2) ISOHEXADECANE (UNII: 918X1OUF1E) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: 657L0NC5MT) PETROLATUM (UNII: 4T6H12BN9U) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) KAOLIN (UNII: 24H4NWX5CO) CHOLESTEROL (UNII: 97C5T2UQ7J) ALOE VERA LEAF (UNII: ZY81Z83H0X) SANTALUM SPICATUM OIL (UNII: H9LVS6REV4) LINOLEIC ACID (UNII: 9KJL21T0QJ) SOYBEAN OIL (UNII: 241ATL177A) STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P) LEVOMENOL (UNII: 24WE03BX2T) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PROPYLENE CARBONATE (UNII: 8D08K3S51E) METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) DIHYDROMYRCENOL (UNII: 46L1B02ND9) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11559-030-01 1 in 1 CARTON 10/01/2010 1 30 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 10/01/2010 Labeler - ESTEE LAUDER INC (005914387) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations Estee Lauder N.V. 370151326 manufacture(11559-030) , pack(11559-030) , label(11559-030)
