![EXTRA REPAIR FOUNDATION BROAD SPECTRUM SPF 25 (OCTINOXATE, HOMOSALATE, OXYBENZONE, AVOBENZONE) CREAM [BOBBI BROWN PROFESSIONAL COSMETICS INC.]](https://medic.hrt.org//dailymed/images/c6dff54d-5a23-4e34-9df5-450647bb16ff/extra-repair-01.jpg)
| NDC | 64141-008-01, 64141-008-02 |
| Set ID | c6dff54d-5a23-4e34-9df5-450647bb16ff |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Bobbi Brown Professional Cosmetics Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- 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)
