Label: EXTRA REPAIR FOUNDATION BROAD SPECTRUM SPF 25- octinoxate, homosalate, oxybenzone, avobenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 64141-008-01, 64141-008-02 - Packager: Bobbi Brown Professional Cosmetics Inc.
- Category: HUMAN OTC DRUG LABEL
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 6, 2012
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
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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, regulary 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-sleezed shirts, pants, hats and sunglasses
- children under 6 months of age: ask a doctor
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Inactive ingredients
water\aqua\eau • glycerin • bis-diglyceryl polyacyladipate-2 • butyrospermum parkii (shea butter) • peg-4 diheptanoate • cetearyl alcohol • cetyl alcohol • glyceryl stearate • hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer • epilobium angustifolium extract • rosmarinus officinalis (rosemary) • oenothera biennis (evening primrose) oil • pelargonium graveolens (geranium) flower oil • angelica archangelica seed oil • citrus aurantium amara (bitter orange) oil • astrocaryum murumuru seed butter • anthemis nobilis (chamomile) • acetyl hexapeptide-8 • lecithin • dimethicone • phenyl trimethicone • propylene glycol laurate • sorbitan stearate • peg-40 stearate • squalane • ethylhexylglycerin • butylene glycol • dicetylphosphate • ceteth-10 phosphate • polysorbate 60 • peg-12 dimethicone • citrus grandis (grapefruit) peel oil • propylene glycol stearate • sodium hyaluronate • sorbitan laurate • polysorbate 20 • citric acid • tocopheryl acetate • xanthan gum • alumina • pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate • tetrasodium edta • limonene • linalool • citral • geraniol • citronellol • potassium sorbate • phenoxyethanol • chlorphenesin • [+/- titanium dioxide (ci 77891) • iron oxides (ci 77491, ci 77492, ci 77499) • mica]<iln38338>
- Other information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 ml Jar Carton
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INGREDIENTS AND APPEARANCE
EXTRA REPAIR FOUNDATION BROAD SPECTRUM SPF 25
octinoxate, homosalate, oxybenzone, avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64141-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5.0 mL in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5.0 mL in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.0 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SHEA BUTTER (UNII: K49155WL9Y) GLYCERIN (UNII: PDC6A3C0OX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG) EVENING PRIMROSE OIL (UNII: 3Q9L08K71N) ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R) CARROT (UNII: L56Z1JK48B) CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) DIMETHICONE (UNII: 92RU3N3Y1O) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) SQUALANE (UNII: GW89575KF9) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYSORBATE 60 (UNII: CAL22UVI4M) PROPYLENE GLYCOL MONOPALMITOSTEARATE (UNII: F76354LMGR) SORBITAN MONOLAURATE (UNII: 6W9PS8B71J) POLYSORBATE 20 (UNII: 7T1F30V5YH) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64141-008-01 1 in 1 CARTON 1 NDC:64141-008-02 30 mL in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/01/2010 Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279) Establishment Name Address ID/FEI Business Operations ELGC K.K. 712808195 RELABEL(64141-008) , REPACK(64141-008) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(64141-008) , RELABEL(64141-008) , REPACK(64141-008) Establishment Name Address ID/FEI Business Operations Estee Lauder Inc. 042918826 MANUFACTURE(64141-008) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(64141-008) , RELABEL(64141-008) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(64141-008) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(64141-008) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(64141-008) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(64141-008) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(64141-008) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 943871157 MANUFACTURE(64141-008) , RELABEL(64141-008) , REPACK(64141-008) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 959338336 MANUFACTURE(64141-008) , RELABEL(64141-008) , REPACK(64141-008) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 949264774 MANUFACTURE(64141-008) , RELABEL(64141-008) , REPACK(64141-008) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(64141-008) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(64141-008) Establishment Name Address ID/FEI Business Operations Pennsylvania Logistics Center 078364654 REPACK(64141-008) , RELABEL(64141-008)