Label: AGE DEFENSE BB BROAD SPECTRUM SPF 30 ALL SKIN TYPES- octinoxate, octisalate, titanium dioxide, and zinc oxide cream
- NDC Code(s): 49527-030-01
- Packager: CLINIQUE LABORATORIES LLC
- 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 April 27, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- 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 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
- children under 6 months of age: ask a doctor
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Inactive ingredients
water\aqua\eau • octyldodecyl neopentanoate • butylene glycol • dimethicone • propanediol • glyceryl stearate • behenyl alcohol • peg-40 stearate • polyglyceryl-10 pentastearate • phenyl trimethicone • polymethylsilsesquioxane • hordeum vulgare (barley) extract\extrait d'orge • triticum vulgare (wheat) germ extract • laminaria saccharina extract • linoleic acid • oryzanol • squalane • caffeine • hydrogenated lecithin • sucrose • glycerin • polyquaternium-51 • lecithin • sodium stearoyl lactylate • polyglyceryl-6 polyricinoleate • sodium pca • isopropyl titanium triisostearate • trehalose • urea • tocopheryl acetate • sodium hyaluronate • ammonium acryloyldimethyltaurate/vp copolymer • xanthan gum • glycyrrhetinic acid • stearic acid • alumina • silica • pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate • disodium edta • chlorphenesin • sodium dehydroacetate • phenoxyethanol • [+/- titanium dioxide (ci 77891) • iron oxides (ci 77491, ci 77492, ci 77499) • mica] [iln39837]
- Other information
- PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton
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INGREDIENTS AND APPEARANCE
AGE DEFENSE BB BROAD SPECTRUM SPF 30 ALL SKIN TYPES
octinoxate, octisalate, titanium dioxide, and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-030 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 44 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 35 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 22 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE (UNII: 92RU3N3Y1O) PROPANEDIOL (UNII: 5965N8W85T) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) DOCOSANOL (UNII: 9G1OE216XY) PEG-40 STEARATE (UNII: ECU18C66Q7) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) WHEAT GERM (UNII: YR3G369F5A) SACCHARINA LATISSIMA (UNII: 68CMP2MB55) LINOLEIC ACID (UNII: 9KJL21T0QJ) ORYZANOL (UNII: SST9XCL51M) SQUALANE (UNII: GW89575KF9) CAFFEINE (UNII: 3G6A5W338E) SUCROSE (UNII: C151H8M554) GLYCERIN (UNII: PDC6A3C0OX) SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) TREHALOSE (UNII: B8WCK70T7I) UREA (UNII: 8W8T17847W) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) XANTHAN GUM (UNII: TTV12P4NEE) ENOXOLONE (UNII: P540XA09DR) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM OXIDE (UNII: LMI26O6933) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) EDETATE DISODIUM (UNII: 7FLD91C86K) CHLORPHENESIN (UNII: I670DAL4SZ) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-030-01 1 in 1 CARTON 05/01/2013 1 40 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 05/01/2013 Labeler - CLINIQUE LABORATORIES LLC (044475127) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations PALC 078364654 label(49527-030) , pack(49527-030) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 204132062 pack(49527-030) , label(49527-030) Establishment Name Address ID/FEI Business Operations Whitman Laboratories Ltd. 216866277 manufacture(49527-030) , pack(49527-030) , label(49527-030) Establishment Name Address ID/FEI Business Operations Estee Lauder N.V. 370151326 manufacture(49527-030) , pack(49527-030) , label(49527-030) Establishment Name Address ID/FEI Business Operations The Estee Lauder Inc 802599436 manufacture(49527-030) , pack(49527-030) , label(49527-030) Establishment Name Address ID/FEI Business Operations Northtec LLC 943871157 pack(49527-030) , label(49527-030) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 pack(49527-030) , label(49527-030)
